AbbVie Receives Positive CHMP Opinion for Upadacitinib for the Treatment of Adults with Moderate to Severe Crohn's Disease

The positive CHMP opinion for upadacitinib is based on results from two induction studies and one maintenance study ^1-4
Crohn's disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal tract, causing persistent diarrhea and abdominal pain ^5,6
If approved by the European Commission (EC), this will be the seventh indication for upadacitinib in the European Union (EU), and the first JAK inhibitor for Crohn's disease, adding to AbbVie's gastroenterology portfolio

ABBVie (NYSE: ABBV) today announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of upadacitinib (RINVOQ ® 45 mg [induction dose] and 15 mg and 30 mg [maintenance doses]) for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent. 1-4

"The recent CHMP recommendation to approve upadacitinib for use in Crohn's disease is a momentous step, bringing us closer to offering a first-of-its-kind, once-daily oral treatment that can make a difference for people living with this disease," said Roopal Thakkar, M.D., senior vice president, development, regulatory affairs and chief medical officer, AbbVie. "We remain steadfast in our commitment to researching and developing treatment options as part of a diverse portfolio of therapies for those living with inflammatory bowel diseases."

AbbVie's application for the approval of upadacitinib in Crohn's disease is supported by data from two induction studies, U-EXCEED and U-EXCEL, and one maintenance study, U-ENDURE. ¹ Patients receiving upadacitinib were treated with 45 mg once daily for the induction studies, and were randomized to receive either 15 mg or 30 mg once-daily doses for the maintenance study. ^1-4 Across all three Phase 3 studies, a significantly greater proportion of patients treated with upadacitinib achieved the co-primary endpoints of clinical remission per SF/AP (defined as average daily stool frequency [SF] ≤2.8 and abdominal pain [AP] score ≤1.0 and neither greater than baseline) and endoscopic response (defined as decrease in simple endoscopic score for Crohn's disease [SES-CD] >50% from baseline of the induction) compared to placebo. ^1-4

In all three studies, a statistically significant greater proportion of patients treated with upadacitinib achieved the key secondary endpoint of endoscopic remission (defined as SES-CD ≤4 and at least a 2-point reduction vs. baseline and no subscore >1). Additionally, more upadacitinib-treated patients achieved SES-CD ulcerated surface subscore of 0 at weeks 12 and 52 (nominal p-value 1-4,* Absence or disappearance of ulceration coupled with improvements seen by endoscopy are associated with mucosal healing. ^7-10

The safety profile of upadacitinib in Crohn's disease was generally consistent with the known safety profile of upadacitinib. ^1-4 Similar rates of serious adverse events including serious infections were observed between patients receiving upadacitinib and placebo. Reports of malignancy, major cardiovascular events, venous thromboembolic events and gastrointestinal perforation were infrequently observed (

"The impact of Crohn's disease extends beyond the gut to include systemic symptoms such as fatigue, bowel symptoms and social and emotional functioning. Treatment options that achieve critical endpoints such as clinical remission and endoscopic response can make a difference in managing the challenging symptoms of this condition and health-related outcomes related to quality of life," said Jean-Frédéric Colombel, M.D., professor of medicine and director of Inflammatory Bowel Disease Center, Icahn School of Medicine, Mount Sinai and study investigator. "Upadacitinib could be a promising treatment option for patients who live with uncontrolled moderate to severe Crohn's disease. I look forward to the European Commission's final decision."

RINVOQ is approved in the EU for the treatment of adults with radiographic axial spondylarthritis, non-radiographic axial spondylarthritis, psoriatic arthritis, rheumatoid arthritis, moderately to severely active ulcerative colitis and adults and adolescents with atopic dermatitis. ^1,11-15

Use of upadacitinib in Crohn's disease is approved in Great Britain as of January 2023 . Its safety and efficacy remain under evaluation in the European Union.

About Crohn's Disease
Crohn's disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal tract, causing persistent diarrhea and abdominal pain. ^5,6 It is a progressive disease, meaning it gets worse over time in a substantial proportion of patients or may develop complications that require urgent medical care, including surgery. ^5,6 Because the signs and symptoms of Crohn's disease are unpredictable, it causes a significant burden on people living with the disease—not only physically, but also emotionally and economically. ^5,6

About the U-EXCEED and U-EXCEL Inductions Studies, and the U-ENDURE Maintenance Study ^1-4 The three Phase 3 studies are multicenter, randomized, double-blind, placebo-controlled studies to evaluate the efficacy and safety of upadacitinib 45 mg as induction therapy and upadacitinib 15 mg and 30 mg as maintenance therapy in patients with moderately to severely active Crohn's disease. Topline results of the U-EXCEED and U-EXCEL induction studies were announced in December 2021 and February 2022 . Topline results of the U-ENDURE maintenance study were announced in May 2022 . More information can be found on www.clinicaltrials.gov (U-EXCEED: NCT03345836, U-EXCEL: NCT03345849, U-ENDURE: NCT03345823).

About Upadacitinib (RINVOQ ^® )
Discovered and developed by AbbVie scientists, upadacitinib (RINVOQ) is a selective and reversible Janus Kinase (JAK) inhibitor. ¹ In human cellular assays, upadacitinib preferentially inhibits signaling by JAK1 or JAK1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2. ¹

Phase 3 trials of RINVOQ in Crohn's disease, giant cell arteritis and Takayasu arteritis are ongoing. ^1,16-18

EU Indications and Important Safety Information about Upadacitinib (RINVOQ ^® ) ¹
Indications

Rheumatoid arthritis

RINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). RINVOQ may be used as monotherapy or in combination with methotrexate.

Psoriatic arthritis

RINVOQ is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. RINVOQ may be used as monotherapy or in combination with methotrexate.

Axial spondyloarthritis

Non-radiographic axial spondyloarthritis (nr-axSpA)

RINVOQ is indicated for the treatment of active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).

Ankylosing spondylitis (AS, radiographic axial spondyloarthritis)

RINVOQ is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy.

Atopic dermatitis

RINVOQ is indicated for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents 12 years and older who are candidates for systemic therapy.

Ulcerative colitis

RINVOQ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.

Important Safety Information

Contraindications
RINVOQ is contraindicated in patients hypersensitive to the active substance or to any of the excipients, in patients with active tuberculosis (TB) or active serious infections, in patients with severe hepatic impairment, and during pregnancy.

Special warnings and precautions for use

Immunosuppressive medicinal products
Use in combination with other potent immunosuppressants is not recommended.

Serious infections
Serious and sometimes fatal infections have been reported in patients receiving upadacitinib. The most frequent serious infections reported included pneumonia and cellulitis. Cases of bacterial meningitis have been reported. Among opportunistic infections, TB, multidermatomal herpes zoster, oral/esophageal candidiasis, and cryptococcosis have been reported with upadacitinib. As there is a higher incidence of infections in patients ≥65 years of age, caution should be used when treating this population. Upadacitinib should be interrupted if a patient develops a serious or opportunistic infection.

Tuberculosis
Patients should be screened for TB before starting upadacitinib. Upadacitinib should not be given to patients with active TB. Anti-TB therapy may be appropriate for select patients in consultation with a physician with expertise in the treatment of TB. Patients should be monitored for the development of signs and symptoms of TB.

Viral reactivation
Viral reactivation, including cases of herpes zoster, was reported in clinical studies. The risk of herpes zoster appears to be higher in Japanese patients treated with upadacitinib. Consider interruption of upadacitinib if the patient develops herpes zoster.

Vaccinations
The use of live, attenuated vaccines during or immediately prior to therapy is not recommended. It is recommended that patients be brought up to date with all immunizations, including prophylactic zoster vaccinations, prior to initiating upadacitinib, in agreement with current immunization guidelines.

Malignancy
The risk of malignancies, including lymphoma is increased in patients with rheumatoid arthritis (RA). Malignancies, including nonmelanoma skin cancer (NMSC), have been reported in patients treated with upadacitinib. Consider the risks and benefits of upadacitinib treatment prior to initiating therapy in patients with a known malignancy other than a successfully treated NMSC or when considering continuing upadacitinib therapy in patients who develop a malignancy. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.

Hematological abnormalities
Treatment should not be initiated, or should be temporarily interrupted, in patients with hematological abnormalities observed during routine patient management.

Diverticulitis
Upadacitinib should be used with caution in patients with diverticular disease and especially in patients chronically treated with concomitant medications associated with an increased risk of diverticulitis.

Cardiovascular risk
RA patients have an increased risk for cardiovascular disorders. Patients treated with upadacitinib should have risk factors (e.g., hypertension, hyperlipidemia) managed as part of usual standard of care.

Lipids
Upadacitinib treatment was associated with dose-dependent increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol.

Hepatic transaminase elevations
Treatment with upadacitinib was associated with an increased incidence of liver enzyme elevation. If alanine transaminase (ALT) or aspartate transaminase (AST) increases are observed and drug-induced liver injury is suspected, upadacitinib should be interrupted until this diagnosis is excluded.

Venous thromboembolisms
Events of deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients receiving JAK inhibitors, including upadacitinib. Upadacitinib should be used with caution in patients at high risk for DVT/PE. If clinical features of DVT/PE occur, upadacitinib should be discontinued and patients should be evaluated and treated appropriately.

Elderly
There is an increased risk of adverse reactions with the upadacitinib dose of 30 mg once daily in patients aged 65 years and older. The recommended dose for long-term use is 15 mg once daily for this patient population.

Hypersensitivity reactions
Serious hypersensitivity reactions such as anaphylaxis and angioedema have been reported in patients receiving upadacitinib. If a clinically significant hypersensitivity reaction occurs, discontinue upadacitinib and institute appropriate therapy.

Adverse reactions
The most commonly reported adverse reactions in RA, PsA, and axSpA clinical trials (≥2% of patients in at least one of the indications) with upadacitinib 15 mg were upper respiratory tract infections, blood creatine phosphokinase (CPK) increased, ALT increased, bronchitis, nausea, neutropenia, cough, AST increased, and hypercholesterolemia. Overall, the safety profile observed in patients with psoriatic arthritis or active axial spondyloarthritis treated with RINVOQ 15 mg was consistent with the safety profile observed in patients with RA.

The most commonly reported adverse reactions in atopic dermatitis trials (≥2% of patients) with RINVOQ 15 mg or 30 mg were upper respiratory tract infection, acne, herpes simplex, headache, CPK increased, cough, folliculitis, abdominal pain, nausea, neutropenia, pyrexia, and influenza. Dose-dependent increased risks of infection and herpes zoster were observed with upadacitinib. The safety profile for upadacitinib 15 mg in adolescents was similar to that in adults. The safety and efficacy of the 30 mg dose in adolescents are still being investigated.

The most commonly reported adverse reactions in UC trials (≥3% of patients) with upadacitinib 45 mg, 30 mg or 15 mg were upper respiratory tract infection, blood CPK increased, acne, neutropenia, rash, herpes zoster, hypercholesterolemia, folliculitis, herpes simplex, and influenza. The overall safety profile observed in patients with ulcerative colitis was generally consistent with that observed in patients with RA.

The most common serious adverse reactions were serious infections.

The safety profile of upadacitinib with long-term treatment was generally similar to the safety profile during the placebo-controlled period across indications.

This is not a complete summary of all safety information.

See RINVOQ full Summary of Product Characteristics (SmPC) at www.ema.europa.eu

Globally, prescribing information varies; refer to the individual country product label for complete information.

About AbbVie in Gastroenterology
With a robust clinical trial program, AbbVie is committed to cutting-edge research to drive exciting developments in inflammatory bowel diseases (IBD), like ulcerative colitis and Crohn's disease. By innovating, learning and adapting, AbbVie aspires to eliminate the burden of IBD and make a positive long-term impact on the lives of people with IBD. For more information on AbbVie in gastroenterology, visit https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/gastroenterology.html .

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , LinkedIn or Instagram .

Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc ("Allergan"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2021 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

References:

Abbvie, Ltd. RINVOQ (upadacitinib) [summary of product characteristics]. Available at: https://www.ema.europa.eu/en/documents/product-information/rinvoq-epar-product-information_en.pdf . Accessed on December 7, 2022 .
Colombel, J.F., Panes, J., Lacerda, A.P., et al. Efficacy and Safety of Upadacitinib Induction Therapy in Patients with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologics: Results from a Randomized Phase 3 U-EXCEED Study. UEG Journal. 2022;S-1934. Accessed on December 12, 2022 .
Loftus, E., Colombel, L.F., Lacerda, A.P., et al. Efficacy and Safety of Upadacitinib Induction Therapy in Patients with Moderately to Severely Active Crohn's Disease: Results from a Randomized Phase 3 U-EXCEL Study. UEG Journal. 2022; 10(8): 103-104. doi/10.1002/ueg2.12293. Accessed on December 12, 2022 .
Panes, J., Loftus, E., Lacerda, A.P., et al. Efficacy and Safety of Upadacitinib Maintenance Therapy in Patients with Moderately to Severely Active Crohn's Disease: Results from a Randomized Phase 3 U-ENDURE Maintenance Study. American College of Gastroenterology. 2022: 1-14. Accessed on December 12, 2022 .
Crohn's disease. Symptoms and Causes. Mayo Clinic. Available at: https://www.mayoclinic.org/diseases-conditions/crohns-disease/symptoms-causes/syc-20353304 . Accessed on December 7, 2022 .
The Facts about Inflammatory Bowel Diseases. Crohn's & Colitis Foundation of America. 2014. Available at: https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf . Accessed on December 7, 2022 .
Turner D, Ricciuto A, Lewis A, et al. STRIDE-II: an update on the selecting therapeutic targets in inflammatory bowel disease (STRIDE) initiative of the International Organization for the Study of IBD (IOIBD): determining therapeutic goals for treat-to-target strategies in IBD. Gastroenterology. 2021;160(5):1570-1583. doi:10.1053/j.gastro.2020.12.031.
Dave M, Loftus EV. Mucosal healing in inflammatory bowel disease—a true paradigm of success? Gastroenterol Hepatol. 2012;8(1):29-38.
Daperno M, Castiglione F, de Ridder L, et al. Results of the 2nd part Scientific Workshop of the ECCO. II: Measures and markers of prediction to achieve, detect, and monitor intestinal healing in inflammatory bowel disease. J Crohns Colitis. 2011;5(5):484-498. doi:10.1016/j.crohns.2011.07.003.
European Medicines Agency. Guideline on the Development of New Medicinal Products for the Treatment of Ulcerative Colitis. EMA Committee for Medicinal Products for Human Use (CHMP); 2018:18. Accessed February 20, 2022 . https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-development-new-medicinal-products-treatment-ulcerative-colitis-revision-1_en.pdf.
Guttman-Yassky E, Teixeira HD, Simpson EL, et al. Once-daily upadacitinib versus placebo in adolescents and adults with moderate-to-severe atopic dermatitis (Measure Up 1 and Measure Up 2): results from two replicate double-blind, randomised controlled phase 3 trials. The Lancet . 2021;397(10290):2151-2168. doi:10.1016/S0140-6736(21)00588-2
Cohen SB, van Vollenhoven RF, Winthrop KL, et al. Safety profile of upadacitinib in rheumatoid arthritis: integrated analysis from the SELECT phase III clinical programme. Ann Rheum Dis . Published online October 28 , 2020:annrheumdis-2020-218510. doi:10.1136/annrheumdis-2020-218510
van der Heijde D, Song IH, Pangan AL, et al. Efficacy and safety of upadacitinib in patients with active ankylosing spondylitis (SELECT-AXIS 1): a multicentre, randomised, double-blind, placebo-controlled, phase 2/3 trial. Lancet . 2019;394(10214):2108-2117. doi:10.1016/S0140-6736(19)32534-6
Mease PJ, Lertratanakul A, Anderson JK, et al. Upadacitinib for psoriatic arthritis refractory to biologics: SELECT-PsA 2. Annals of the Rheumatic Diseases . 2021;80(3):312-320. doi:10.1136/annrheumdis-2020-218870
Danese, S, Vermeire, S, Zhou, W, et al. Upadacitinib as induction and maintenance therapy for moderately to severely active ulcerative colitis: results from three phase 3, multicentre, double-blind, randomised trials. The Lancet. 2022;399(10341):2113-2128. doi: 10.1016/S0140-6736(22)00581-5.
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A Study to Evaluate the Efficacy and Safety of Upadacitinib in Subjects With Takayasu Arteritis (TAK) (SELECT-TAK). ClinicalTrials.gov. 2022. Available at: https://clinicaltrials.gov/ct2/show/NCT04161898 . Accessed on December 7, 2022.

* Mucosal healing was a prespecified endpoint, not controlled for multiplicity.

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Health Canada Approves AbbVie's RINVOQ® for the Treatment of Adults with Active Non-Radiographic Axial Spondyloarthritis

- Approval is based on results from the Phase 3 SELECT-AXIS 2 pivotal clinical trial in which RINVOQ delivered rapid and meaningful disease control, meeting the primary endpoint of ASAS40 response at week 14 versus placebo ¹ - RINVOQ is the first and only Janus Kinase (JAK) inhibitor approved to treat patients across the spectrum of axial spondyloarthritis (nr-axSpA and ankylosing spondylitis) in Canada ^{1, 2, 3}

AbbVie (NYSE: ABBV), today announced that Health Canada has approved RINVOQ ® (upadacitinib, 15 mg), the first oral, once-daily selective and reversible JAK inhibitor for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation who have had an inadequate response to a biologic disease modifying anti-rheumatic drug (DMARD) or when use of those therapies is inadvisable.

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Sirona Biochem Announces Exclusive Global Licensing Agreement with Allergan Aesthetics

Sirona Biochem Corp . (TSX-V: SBM) (FSE: ZSB) (OTC: SRBCF) (" Sirona ") is pleased to announce it has entered into a global exclusive licensing agreement with Allergan Aesthetics, an AbbVie company (NYSE: ABBV), pursuant to which Allergan Aesthetics will develop and commercialize topical skin care treatments based on active ingredients derived from certain of Sirona's patents for TFC-1067 and related family of compounds.

"We are very pleased to have finalized terms with a global leader in medical aesthetics and the innovator behind SkinMedica™, a leader in the science of skin rejuvenation," said Dr. Howard Verrico, CEO of Sirona Biochem. "Our most recent clinical trial of TFC-1067 was a collaborative effort with Allergan Aesthetics to demonstrate the clinical potential in topical skin care treatments. This further validates our platform technology as viable for additional commercial products which we are actively pursuing. We would like to thank Dr. Linda Pullan of Pullan Consulting who assisted with our current success."

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Biogen and AbbVie Receive Positive Opinion from the CHMP on ZINBRYTA™ (Daclizumab) for Treatment of Multiple Sclerosis

CAMBRIDGE, Mass. & NORTH CHICAGO, Ill.–(BUSINESS WIRE)–The Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) has adopted a positive opinion
recommending the granting of a marketing authorization for ZINBRYTA™
(daclizumab) intended for the treatment of relapsing forms of multiple
sclerosis (RMS), Biogen
(NASDAQ: BIIB) and AbbVie (NYSE:
ABBV) announced today. ZINBRYTA is a once-monthly, self-administered,
subcutaneous investigational treatment for RMS. ZINBRYTA is also
currently under regulatory review in the United States, Switzerland,
Canada and Australia.
“For people with relapsing forms of MS (RMS) and active disease,
ZINBRYTA has the potential to offer robust efficacy, a manageable safety
profile through patient monitoring, and once-monthly subcutaneous
dosing,” said Alfred Sandrock, M.D., Ph.D., executive vice president and
chief medical officer at Biogen. “ZINBRYTA may offer another option for
people with multiple sclerosis (MS) with its targeted mechanism of
action (MOA) which did not cause broad and prolonged immune cell
depletion.”
The CHMP positive opinion is now referred to the European Commission
(EC), which grants marketing authorizations for centrally authorized
medicines in the European Union. A decision from the EC is expected
within the coming months.
“Together with Biogen, AbbVie is committed to meeting the needs of
patients with MS, and the positive opinion issued by the CHMP is a
critical step that moves us closer to bringing ZINBRYTA to patients in
Europe,” said Michael Severino, M.D., executive vice president, research
and development and chief scientific officer, AbbVie.
According to the CHMP opinion, the benefits of ZINBRYTA are its ability
to reduce the annualized relapse rate (ARR), as well as the risk of
24-week confirmed disability progression. The opinion is based on
results from two clinical trials, DECIDE and SELECT, in which ZINBRYTA
150 mg, administered subcutaneously every four weeks improved results on
key measures of MS disease activity in patients with RMS compared to
AVONEX 30 mcg intramuscular injection administered weekly and placebo,
respectively.
In the DECIDE study, the overall incidence of adverse events was similar
in the ZINBRYTA and AVONEX groups. In patients treated with ZINBRYTA
compared to AVONEX, there was an increased incidence of serious
infections (4% versus 2%), serious cutaneous reactions (2% versus <1%),
elevations of liver transaminases greater than five times the upper
limit of normal (6% versus 3%), gastrointestinal disorders (31% versus
24%), and depression (8% versus 6%).
About ZINBRYTA™ (daclizumab)
ZINBRYTA (daclizumab) is an investigational compound being developed for
the treatment of relapsing forms of MS. ZINBRYTA is a new form of a
humanized monoclonal antibody that selectively binds to the
high-affinity interleukin-2 (IL-2) receptor subunit (CD25) that is
expressed at high levels on T-cells that become activated in people with
MS. ZINBRYTA modulates IL-2 signaling without general immune cell
depletion.
Biogen and AbbVie are jointly developing ZINBRYTA.
About Biogen
Through cutting-edge science and medicine, Biogen discovers, develops
and delivers worldwide innovative therapies for people living with
serious neurological, autoimmune and rare diseases. Founded in 1978,
Biogen is one of the world’s oldest independent biotechnology companies
and patients worldwide benefit from its leading multiple sclerosis and
innovative hemophilia therapies. For more information, please visit www.biogen.com.
Follow us on Twitter.
Biogen Safe Harbor
This press release contains forward-looking statements, including
statements about the anticipated timing of the EC’s decision on the
marketing authorization for ZINBRYTA, and potential impact of ZINBRYTA,
if approved. These statements may be identified by words such as
“believe,” “expect,” “may,” “potential,” “will” and similar expressions,
and are based on our current beliefs and expectations. You should not
place undue reliance on these statements. Drug development and
commercialization involve a high degree of risk. Factors which could
cause actual results to differ materially from our current expectations
include the risk that the EC may fail to approve or may delay approval
of ZINBRYTA or may not follow the recommendation of the CHMP,
uncertainty of success in commercialization of ZINBRYTA For more
detailed information on the risks and uncertainties associated with our
drug development and commercialization activities and risks relating to
our collaborations with third parties, please review the Risk Factors
section of our most recent annual or quarterly report filed with the
Securities and Exchange Commission. Any forward-looking statements speak
only as of the date of this press release and we assume no obligation to
update any forward-looking statements, whether as a result of new
information, future events or otherwise.
About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in
2013 following separation from Abbott Laboratories. The company’s
mission is to use its expertise, dedicated people and unique approach to
innovation to develop and market advanced therapies that address some of
the world’s most complex and serious diseases. Together with its
wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000
people worldwide and markets medicines in more than 170 countries. For
further information on the company and its people, portfolio and
commitments, please visit www.abbvie.com.
Follow @abbvie on
Twitter or view careers on our Facebook or LinkedIn
page.
Forward-Looking Statements
Some statements in this news release may be forward-looking statements
for purposes of the Private Securities Litigation Reform Act of 1995.
The words “believe,” “expect,” “anticipate,” “project” and similar
expressions, among others, generally identify forward-looking
statements. AbbVie cautions that these forward-looking statements are
subject to risks and uncertainties that may cause actual results to
differ materially from those indicated in the forward-looking
statements. Such risks and uncertainties include, but are not limited
to, challenges to intellectual property, competition from other
products, difficulties inherent in the research and development process,
adverse litigation or government action, and changes to laws and
regulations applicable to our industry.
Additional information about the economic, competitive, governmental,
technological and other factors that may affect AbbVie’s operations is
set forth in Item 1A, “Risk Factors,” in AbbVie’s 2014 Annual Report on
Form 10-K, which has been filed with the Securities and Exchange
Commission. AbbVie undertakes no obligation to release publicly any
revisions to forward-looking statements as a result of subsequent events
or developments, except as required by law.

Enbrel Biosimilar Marks Victory for Merck and Samsung

The biosimilar alliance between Merck (NYSE:MRK) and Samsung Bioepis appears to have paid off, as the companies have won South Korean approval for their copy of Amgen’s (NASDAQ:AMGN) blockbuster drug Enbrel.
According to Fierce Biotech:

Korea’s Ministry of Food and Drug Safety signed off on the injection, to be marketed as Brenzys, to treat rheumatoid arthritis, psoriatic arthritis, spondyloarthritis and psoriasis in adults. The biosimilar, developed as SB4, proved itself equivalent to Amgen’s cash cow in a 596-patient study disclosed this year, reducing symptoms of rheumatoid arthritis on pace with its reference product, according to Merck and Samsung.
Brenzys’ approval marks the first marketing victory for the two companies, a milestone Merck hopes will be a harbinger of future success in biosimilars.
The approval could also have major implications for Samsung Bioepis, long rumored to be considering a U.S. IPO. Details of the company’s Wall Street plans have been tricking out for months, and The Wall Street Journal reported in August that Samsung is planning a $1 billion debut offering for its biologics division, valuing the company at about $7 billion.
Samsung Bioepis, a joint venture with Biogen ($BIIB) that is 85% owned by the South Korean company, joined forces with Merck in 2013 in a wide-ranging deal designed to crack the growing market for off-patent biological treatments. Beyond Enbrel, the pair are working on copies of the similar Humira from AbbVie ($ABBV) and Remicade from Johnson & Johnson ($JNJ). The companies are also developing biosimilars of Sanofi’s ($SNY) blockbuster insulin Lantus and Roche’s ($RHHBY) cancer treatment Herceptin.

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Cardiex Announces Publication of Breakthrough Study Validating Noninvasive Fingertip Photoplethysmography for Central Aortic Pressure Waveform Analysis

- Cardiex Limited (ASX: CDX), a global health technology company focused on cardiovascular diagnostics and arterial health solutions, today announced the publication of a peer-reviewed study validating its innovative method for measuring central aortic pressure—an important indicator of heart health—using a noninvasive fingertip sensor. The study, co-authored by Cardiex's team, was published in the respected journal Pulse.

The study, titled "Validation of Noninvasive Derivation of the Central Aortic Pressure Waveform from Fingertip Photoplethysmography Using a Novel Selective Transfer Function Method," demonstrates that Cardiex's technology can accurately capture key cardiovascular data from a simple fingertip sensor. The method leverages photoplethysmography (PPG)—an optical technique widely used in wearables such as fitness trackers and smartwatches—offering a powerful and accessible tool for advanced heart health monitoring.

Key findings include:

Strong correlation between fingertip sensor measurements and traditional methods, with heart health indicators showing excellent alignment.
The fingertip sensor offers a user-friendly, noninvasive way to measure central aortic pressure parameters without calibration, making heart health monitoring more accessible and comfortable.
Twenty clinically relevant parameters were captured from the converted PPG waveforms, including central systolic blood pressure, central diastolic blood pressure, central pulse pressure, central augmentation pressure, central augmentation index, subendocardial viability, and pulse pressure amplification, amongst others.

Relevance in the Wearable Health Market:

The use of PPG technology in this study is especially significant as the wearable market continues to expand, with consumers seeking more advanced health insights without the need for frequent calibration. Cardiex's innovation aligns with this trend offering consumers the ability to track clinical grade biomarkers in real-time. These biomarkers have applications in various healthcare fields, including cognitive, renal, maternal, metabolic health, and heart failure management. The technology's ease of use and capacity for continuous monitoring place Cardiex at the forefront of the growing wearable health sector, which increasingly prioritizes deeper and more accurate health data.

"This study is a significant validation of Cardiex's technology and its ability to deliver critical heart health insights in a simpler, more convenient way," said Craig Cooper , CEO of Cardiex. "Our PPG-based fingertip technology has the potential to transform heart health monitoring, offering a more accessible option for both patients and healthcare providers. This breakthrough also opens up exciting opportunities for integration into the wearable health tech market, where continuous and noninvasive monitoring is becoming the gold standard."

The study confirms that Cardiex's PPG-based solution can provide valuable cardiovascular data in a comfortable, portable format, paving the way for broader adoption in both medical and consumer-grade wearables.

The full study is now available online in the journal Pulse DOI: 10.1159/000540666.

View original content to download multimedia: https://www.prnewswire.com/news-releases/cardiex-announces-publication-of-breakthrough-study-validating-noninvasive-fingertip-photoplethysmography-ppg-for-central-aortic-pressure-waveform-analysis-302259185.html

SOURCE Cardiex Limited

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TEPEZZA® RECEIVES APPROVAL IN JAPAN FOR THE TREATMENT OF ACTIVE THYROID EYE DISEASE

Amgen (NASDAQ:AMGN) today announced TEPEZZA ® (JAN: Teprotumumab (Genetical Recombination)) has been approved for the treatment of active or high clinical activity score (CAS) Thyroid Eye Disease (TED) by Japan's Ministry of Health, Labour and Welfare (MHLW).

TED is a serious, progressive and potentially vision-threatening rare autoimmune disease that can cause proptosis (eye bulging), diplopia (double vision), eye pain, redness and swelling. ¹ There are approximately 25,000 - 35,000 people living with TED in Japan , inclusive of both active and chronic (low CAS) TED. ² TEPEZZA is now the first and only medicine approved in Japan to treat active TED. A separate trial to study the efficacy of TEPEZZA in chronic TED patients in Japan is currently ongoing.

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AMGEN TO HOST CONFERENCE CALL TO DISCUSS NEW TOPLINE DATA IN INFLAMMATION AND RARE DISEASE

Amgen (NASDAQ:AMGN) will host a webcasted call for the investment community at 1:30 p.m. PT on Tuesday, Sept. 24, 2024 to discuss new topline clinical data from the rocatinlimab (AMG 451KHK4083) and UPLIZNA ® (inebilizumab-cdon) Phase 3 programs. Jay Bradner executive vice president of Research and Development and chief scientific officer at Amgen, and other members of the Amgen team will participate. The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

The webcast, as with other selected presentations regarding developments in Amgen's business given by management at certain investor and medical conferences, can be found on Amgen's website, www.amgen.com , under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen's Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

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Cardiol Therapeutics Announces Completion of the MAvERIC Phase II Study in Recurrent Pericarditis with Results to be Presented at the American Heart Association Scientific Sessions 2024

Full clinical data will be reported in an oral presentation at the premier global event for advancements in cardiovascular science and medicine on November 18, 2024

Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, today announced the data from its Phase II open-label MAvERIC-Pilot study investigating the impact of CardiolRx™ administered to patients with symptomatic recurrent pericarditis will be reported in an oral presentation as part of the Laennec Clinician-Educator Award & Lecture that runs from 9:45 a.m. to 11:00 a.m. Central Time, on Monday, November 18th, 2024, at the American Heart Association Scientific Sessions 2024. Dr. S. Allen Luis, Co-Director, Pericardial Diseases Clinic and Associate Professor of Medicine, Department of Cardiovascular Medicine at the Mayo Clinic, will present on behalf of the MAvERIC-Pilot investigators.

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Abstract Title	Presentation Details All times CDT
Crohn's Disease
Efficacy and Safety of Upadacitinib for the Treatment of Fistulas and Fissures in Patients with Crohn's Disease	Oral Presentation #947 AGA IBD: Real World Data and Clinical Trials to Guide Care (Research Forum) May 9, 2023 8:30 – 8:45 AM
Upadacitinib Improves Endoscopic Outcomes in Patients with Moderate to Severely Active Crohn's Disease Irrespective of Previous Failure to Respond to Biologics or Conventional Therapies	Oral Presentation #1031 AGA Controlled Clinical Trials in IBD (Research Forum) May 9, 2023 11:00 – 11:15 AM
Delayed Clinical Responders in Patients with Crohn's Disease Receiving Upadacitinib Therapy	Poster #Tu1705 IBD: Controlled Clinical Trials in Humans (Poster Session) May 9, 2023 12:30 – 1:30 PM
Upadacitinib Pharmacokinetic and Exposure-Response Relationships in Subjects with Crohn's Disease - Analyses of Phase 3 Studies	Poster #Tu1733 IBD: Controlled Clinical Trials in Humans (Poster Session) May 9, 2023 12:30 – 1:30 PM
Additional Risankizumab Treatment Is Effective in Patients with Moderately to Severely Active Crohn's Disease Who Did Not Achieve CDAI Clinical Response with the Initial 12 Week Induction Treatment: Results From the ADVANCE, MOTIVATE, and FORTIFY Studies	Poster #Tu1710 IBD: Controlled Clinical Trials in Humans (Poster Session) May 9, 2023 12:30 – 1:30 PM
Long-Term Efficacy and Safety of Risankizumab Treatment in Patients with Moderately to Severely Active Crohn's Disease: 104-Week Results from the FORTIFY Study	Poster #Tu1730 IBD: Controlled Clinical Trials in Humans (Poster Session) May 9, 2023 12:30 – 1:30 PM
Safety Profile of Risankizumab in Crohn's Disease Patients by Age: Post-hoc Analysis of the Phase 3 ADVANCE, MOTIVATE, and FORTIFY Studies	Poster #Tu1717 IBD: Controlled Clinical Trials in Humans (Poster Session) May 9, 2023 12:30 – 1:30 PM
Functional Constipation
Efficacy and Safety of Linaclotide in Treating Functional Constipation in Pediatric Patients aged 6-17 years: a Phase 3 Pivotal Randomized Placebo-Controlled Trial	Oral Presentation: #145 AGA Pediatric Functional and Motility Disorders (Research Forum) May 6, 2023 10:15 – 10:30 AM
Time to Response of Linaclotide in Treating Functional Constipation in Pediatric Patients aged 6-17 years: Data from a Phase 3 Randomized Placebo-Controlled Trial	Poster #Mo2008 AGA Pediatric Functional and Motility Disorders (Poster Session) May 8, 2023 12:30 – 1:30 PM
Efficacy of Linaclotide in Treating Symptoms of Incomplete Evacuation and Straining in Pediatric Patients with Functional Constipation	Poster #Mo2007 AGA Pediatric Functional and Motility Disorders (Poster Session) May 8, 2023 12:30 – 1:30 PM
Long-term Safety of Linaclotide in Treating Functional Constipation in Pediatric Patients aged 6-17 years: Interim Analysis of an Open Label, Phase 3, Extension Trial	Poster #Mo2016 AGA Pediatric Functional and Motility Disorders (Poster Session) May 8, 2023 12:30 – 1:30 PM
Safety of Linaclotide in Pediatric Patients with Functional Constipation: A Pooled Analysis of Placebo-Controlled, Randomized Controlled Trials	Poster #Mo2015 AGA Pediatric Functional and Motility Disorders (Poster Session) May 8, 2023 12:30 – 1:30 PM
Exocrine Pancreatic Insufficiency
Development, Generalizability of a Clinical Screening Tool for Exocrine Pancreatic Insufficiency (EPI) in Patients with Definite Chronic Pancreatitis	Poster #Mo1419 AGA Exocrine Pancreatic Diseases and Diabetes (Poster Session) May 8, 2023 12:30 – 1:30 PM
Disease State
Patients with Crohn's Disease and Ulcerative Colitis Cycle Through Multiple Medications Prior To Starting Advanced Therapy: A Retrospective Study	Poster #Sa1814 May 6, 2023 12:30 – 1:30 PM
Food Security in Hispanics with IBD: A Barrier to Dietary Management	Poster #EP141 AGA Diet and IBD (ePoster section) May 6, 2023 9:30 AM – 4:00 PM
Incidence Rates of Gastrointestinal Perforation Among Patients with Inflammatory Bowel Disease: Real-world Evidence from a Large US Nationwide Claims Database	Poster #Su1769 IBD: Diagnostics in IBD (Poster Section) May 7, 2023 12:30 – 1:30 PM

PRODUCT NAME	TEPEZZA ^® for Intravenous Infusion 500 mg
Generic Name (JAN)	Teprotumumab (Genetical Recombination)
Indication	Active thyroid eye disease
Precautions related to indications	Hearing disorders (e.g., deafness, hypoacusis, Eustachian tube dysfunction, patulous Eustachian tube, hyperacusis, tinnitus, and tympanic membrane disorder) may occur during treatment with TEPEZZA, and serious and irreversible events have also been reported. Patients eligible for TEPEZZA therapy should be selected based on a thorough understanding of the information provided in "17. Clinical Results," the backgrounds of the patients in the clinical studies, and the results of the studies of the efficacy and safety of TEPEZZA. Clinical studies of the efficacy and safety in patients with mild active thyroid eye disease have not been conducted.
Dose and Administration	The usual adult dosage is 10 mg/kg as teprotumumab (genetical recombination) for the first dose and 20 mg/kg for the second and subsequent doses, administered intravenously every 3 weeks, for a total of 8 infusions.

AbbVie Receives Positive CHMP Opinion for Upadacitinib for the Treatment of Adults with Moderate to Severe Crohn's Disease

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