AbbVie Releases New Data Demonstrating Breadth of Its Gastroenterology Portfolio at 2023 Digestive Disease Week®

AbbVie Releases New Data Demonstrating Breadth of Its Gastroenterology Portfolio at 2023 Digestive Disease Week®

- Oral presentations highlight efficacy and safety outcomes from the upadacitinib (RINVOQ ® ) clinical trial program in adults with moderately to severely active Crohn's disease, and investigational use of linaclotide (LINZESS ® ) in treating functional constipation in pediatric patients aged 6 to 17 years

- Twenty-nine abstracts showcase AbbVie's vast portfolio and continued commitment to changing the way patients living with gastrointestinal disorders manage their condition

AbbVie (NYSE: ABBV) today announced it will present 29 abstracts during the 2023 Digestive Disease Week (DDW) Annual Meeting, May 6-9, 2023 being held in Chicago and virtually.

"Our abstracts showcase our comprehensive, well-researched gastroenterology portfolio," said Celine Goldberger , M.D., vice president, and head of U.S. medical affairs, AbbVie. "This collective evidence underscores data across a range of digestive and inflammatory bowel diseases and reinforces our commitment to improving patient care."

The oral and poster presentations from AbbVie feature research across the company's gastroenterology portfolio, including data on Crohn's disease, ulcerative colitis, and functional constipation. Notable data presentations will include:

  • Two oral presentations and several posters evaluating investigational upadacitinib in adults with moderately to severely active Crohn's disease, including data on fistulas and fissures and among patients who previously failed biologic or conventional treatment.
  • Several posters of risankizumab in adults with moderately to severely active Crohn's disease, including results from three Phase 3 studies (ADVANCE, MOTIVATE, and FORTIFY) assessing risankizumab as induction therapy for patients who did not previously achieve a clinical response to therapy, as well as long-term efficacy and safety data.
  • An oral presentation and posters assessing investigational linaclotide in pediatric patients (ages 6 to 17 years) with functional constipation, including efficacy and safety data from a Phase 3 trial and an interim analysis of long-term safety from an open-label trial.

Select AbbVie abstracts at 2023 DDW are outlined below. The full list of 2023 DDW Annual Meeting e-Posters is available here .

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

SKYRIZI ® (risankizumab-rzaa) is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization of SKYRIZI globally.

LINZESS ® (linaclotide) is part of a collaboration between AbbVie and Ironwood Pharmaceuticals to share development and commercialization of LINZESS in the United States .

The use of upadacitinib in Crohn's disease is not approved by the U.S. Food and Drug Administration (FDA). Its safety and efficacy are under evaluation as part of ongoing registrational studies.

RINVOQ ® (upadacitinib) U.S. Uses and Important Safety Information 1

RINVOQ is a prescription medicine used to treat:

  • Adults with moderate to severe rheumatoid arthritis when 1 or more medicines called tumor necrosis factor (TNF) blockers have been used and did not work well or could not be tolerated.
  • Adults with active psoriatic arthritis when 1 or more medicines called TNF blockers have been used and did not work well or could not be tolerated.
  • Adults with moderately to severely active ulcerative colitis when 1 or more medicines called TNF blockers have been used and did not work well or could not be tolerated.
  • Adults with active ankylosing spondylitis when 1 or more medicines called TNF blockers have been used and did not work well or could not be tolerated.
  • Adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation when a TNF blocker medicine has been used and did not work well or could not be tolerated.

It is not known if RINVOQ is safe and effective in children with juvenile idiopathic arthritis, psoriatic arthritis, ulcerative colitis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis.

  • Adults and children 12 years of age and older with moderate to severe eczema (atopic dermatitis [AD]) that did not respond to previous treatment and their eczema is not well controlled with other pills or injections, including biologic medicines, or when the use of other pills or injections is not recommended.

RINVOQ is safe and effective in children 12 years of age and older weighing at least 88 pounds (40 kg) with atopic dermatitis.

It is not known if RINVOQ is safe and effective in children under 12 years of age with atopic dermatitis.

What is the most important information I should know about RINVOQ?

RINVOQ may cause serious side effects, including:

  • Serious infections. RINVOQ can lower your ability to fight infections. Serious infections have happened while taking RINVOQ, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your healthcare provider (HCP) should test you for TB before starting RINVOQ and check you closely for signs and symptoms of TB during treatment with RINVOQ. You should not start taking RINVOQ if you have any kind of infection unless your HCP tells you it is okay. If you get a serious infection, your HCP may stop your treatment until your infection is controlled. You may be at higher risk of developing shingles (herpes zoster).
  • Increased risk of death in people 50 years and older who have at least 1 heart disease (cardiovascular) risk factor.
  • Cancer and immune system problems. RINVOQ may increase your risk of certain cancers. Lymphoma and other cancers, including skin cancers, can happen. Current or past smokers are at higher risk of certain cancers, including lymphoma and lung cancer. Follow your HCP's advice about having your skin checked for skin cancer during treatment with RINVOQ. Limit the amount of time you spend in sunlight. Wear protective clothing when you are in the sun and use sunscreen.
  • Increased risk of major cardiovascular (CV) events, such as heart attack, stroke, or death, in people 50 years and older who have at least 1 heart disease (CV) risk factor, especially if you are a current or past smoker.
  • Blood clots: Blood clots in the veins of the legs or lungs and arteries can happen with RINVOQ. This may be life-threatening and cause death. Blood clots in the veins of the legs and lungs have happened more often in people who are 50 years and older and with at least 1 heart disease (CV) risk factor.
  • Allergic reactions. Symptoms such as rash (hives), trouble breathing, feeling faint or dizzy, or swelling of your lips, tongue, or throat, that may mean you are having an allergic reaction have been seen in people taking RINVOQ. Some of these reactions were serious. If any of these symptoms occur during treatment with RINVOQ, stop taking RINVOQ and get emergency medical help right away.
  • Tears in the stomach or intestines and changes in certain laboratory tests. Your HCP should do blood tests before you start taking RINVOQ and while you take it. Your HCP may stop your RINVOQ treatment for a period of time if needed because of changes in these blood test results.

Do not take RINVOQ if you are allergic to upadacitinib or any of the ingredients in RINVOQ. See the Medication Guide or Consumer Brief Summary for a complete list of ingredients.

What should I tell my HCP BEFORE starting RINVOQ?
Tell your HCP if you:

  • Are being treated for an infection, have an infection that won't go away or keeps coming back, or have symptoms of an infection such as:
    • Fever, sweating, or chills
    • Shortness of breath
    • Warm, red, or painful skin or sores on your body
    • Muscle aches
    • Feeling tired
    • Blood in phlegm
    • Diarrhea or stomach pain
    • Cough
    • Weight loss
    • Burning when urinating or urinating more often than normal
  • Have TB or have been in close contact with someone with TB.
  • Are a current or past smoker.
  • Have had a heart attack, other heart problems, or stroke.
  • Have had any type of cancer, hepatitis B or C, shingles (herpes zoster), blood clots in the veins of your legs or lungs, diverticulitis (inflammation in parts of the large intestine), or ulcers in your stomach or intestines.
  • Have other medical conditions including liver problems, low red or white blood cell counts, diabetes, chronic lung disease, HIV, or a weak immune system.
  • Live, have lived, or have traveled to parts of the country, such as the Ohio and Mississippi River valleys and the Southwest, that increase your risk of getting certain kinds of fungal infections. If you are unsure if you've been to these types of areas, ask your HCP.
  • Have recently received or are scheduled to receive a vaccine. People who take RINVOQ should not receive live vaccines.
  • Are pregnant or plan to become pregnant. Based on findings in animal studies, RINVOQ may harm your unborn baby. Your HCP will check whether or not you are pregnant before you start RINVOQ. You should use effective birth control (contraception) to avoid becoming pregnant during treatment with RINVOQ and for 4 weeks after your last dose.
  • Are breastfeeding or plan to breastfeed. RINVOQ may pass into your breast milk. Do not breastfeed during treatment with RINVOQ and for 6 days after your last dose.

Tell your HCP about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. RINVOQ and other medicines may affect each other, causing side effects.

Especially tell your HCP if you take:

  • Medicines for fungal or bacterial infections
  • Rifampicin or phenytoin
  • Medicines that affect your immune system

If you are not sure if you are taking any of these medicines, ask your HCP or pharmacist.

What should I avoid while taking RINVOQ?

Avoid food or drink containing grapefruit during treatment with RINVOQ as it may increase the risk of side effects.

What should I do or tell my HCP AFTER starting RINVOQ?

  • Tell your HCP right away if you have any symptoms of an infection. RINVOQ can make you more likely to get infections or make any infections you have worse.
  • Get emergency help right away if you have any symptoms of a heart attack or stroke while taking RINVOQ, including:
    • Discomfort in the center of your chest that lasts for more than a few minutes or that goes away and comes back
    • Severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
    • Pain or discomfort in your arms, back, neck, jaw, or stomach
    • Shortness of breath with or without chest discomfort
    • Breaking out in a cold sweat
    • Nausea or vomiting
    • Feeling lightheaded
    • Weakness in one part or on one side of your body
    • Slurred speech
  • Tell your HCP right away if you have any signs or symptoms of blood clots during treatment with RINVOQ, including:
    • Swelling
    • Pain or tenderness in one or both legs
    • Sudden unexplained chest or upper back pain
    • Shortness of breath or difficulty breathing
  • Tell your HCP right away if you have a fever or stomach-area pain that does not go away, and a change in your bowel habits.

What are other possible side effects of RINVOQ?
Common side effects include upper respiratory tract infections (common cold, sinus infections), shingles (herpes zoster), herpes simplex virus infections (including cold sores), bronchitis, nausea, cough, fever, acne, headache, increased blood levels of creatine phosphokinase, allergic reactions, inflammation of hair follicles, stomach-area (abdominal) pain, increased weight, flu, tiredness, lower number of certain types of white blood cells (neutropenia, lymphopenia), muscle pain, flu-like illness, rash, increased blood cholesterol levels, and increased liver enzyme levels.

A separation or tear to the lining of the back part of the eye (retinal detachment) has happened in people with atopic dermatitis treated with RINVOQ. Call your HCP right away if you have any sudden changes in your vision during treatment with RINVOQ.

These are not all the possible side effects of RINVOQ.

How should I take RINVOQ?
RINVOQ is taken once a day with or without food. Do not split, crush, or chew the tablet. Take RINVOQ exactly as your HCP tells you to use it. RINVOQ is available in 15 mg, 30 mg and 45 mg extended-release tablets.

This is the most important information to know about RINVOQ. For more information, talk to your HCP.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.

Please click here for the Full Prescribing Information and Medication Guide .

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

LINZESS ® (linaclotide) Uses and Important Safety Information 2

USES

LINZESS ® (linaclotide) is a prescription medication used in adults to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC). "Idiopathic" means the cause of the constipation is unknown. It is not known if LINZESS is safe and effective in children less than 18 years of age.

IMPORTANT RISK INFORMATION

  • Do not give LINZESS to children who are less than 2 years of age. It may harm them. LINZESS can cause severe diarrhea and your child could get severe dehydration (loss of a large amount of body water and salt).
  • Do not take LINZESS if a doctor has told you that you have a bowel blockage (intestinal obstruction).

Before you take LINZESS, tell your doctor about your medical conditions, including if you are:

  • Pregnant or plan to become pregnant. It is not known if LINZESS will harm your unborn baby.
  • Breastfeeding or plan to breastfeed. You and your doctor should decide if you will take LINZESS and breastfeed.

Tell your doctor about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Side Effects

LINZESS can cause serious side effects, including diarrhea, which is the most common side effect and can sometimes be severe. Diarrhea often begins within the first 2 weeks of LINZESS treatment. Stop taking LINZESS and call your doctor right away if you get severe diarrhea during treatment with LINZESS.

Other common side effects of LINZESS include gas, stomach-area (abdominal) pain, swelling, or a feeling of fullness or pressure in your abdomen (distension). Call your doctor or go to the nearest hospital emergency room right away if you develop unusual or severe stomach-area (abdominal) pain, especially if you also have bright red, bloody stools or black stools that look like tar.

These are not all the possible side effects of LINZESS. For more information, ask your doctor or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

If you are having difficulty paying for your medicine, AbbVie and Ironwood may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.

Please see full Prescribing Information including Boxed Warning.

SKYRIZI (risankizumab-rzaa) U.S. Uses and Important Safety Information 3

SKYRIZI is a prescription medicine used to treat adults with:

  • moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy).
  • active psoriatic arthritis (PsA).
  • moderate to severe Crohn's disease.

What is the most important information I should know about SKYRIZI ® (risankizumab-rzaa)?

SKYRIZI is a prescription medication that may cause serious side effects, including:

Serious allergic reactions:

  • Stop using SKYRIZI and get emergency help right away if you get any of the following symptoms of serious allergic reaction:
    • Fainting, dizziness, feeling lightheaded (low blood pressure)
    • Swelling of your face, eyelids, lips, mouth, tongue, or throat
    • Trouble breathing or throat tightness
    • Chest tightness
    • Skin rash, hives
    • Itching

Infections:
SKYRIZI may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with SKYRIZI and may treat you for TB before you begin treatment with SKYRIZI if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with SKYRIZI.

  • Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including:
    • Fever, sweats, or chills
    • Cough
    • Shortness of breath
    • Blood in your mucus (phlegm)
    • Muscle aches
    • Warm, red, or painful skin or sores on your body different from your psoriasis
    • Weight loss
    • Diarrhea or stomach pain
    • Burning when you urinate or urinating more often than normal

Do not use SKYRIZI if you are allergic to risankizumab-rzaa or any of the ingredients in SKYRIZI. See the Medication Guide or Consumer Brief Summary for a complete list of ingredients.

Before using SKYRIZI, tell your healthcare provider about all of your medical conditions, including if you:

  • have any of the conditions or symptoms listed in the section " What is the most important information I should know about SKYRIZI? "
  • have an infection that does not go away or that keeps coming back.
  • have TB or have been in close contact with someone with TB.
  • have recently received or are scheduled to receive an immunization (vaccine). Medications that interact with the immune system may increase your risk of getting an infection after receiving live vaccines. You should avoid receiving live vaccines right before, during, or right after treatment with SKYRIZI. Tell your healthcare provider that you are taking SKYRIZI before receiving a vaccine.
  • are pregnant or plan to become pregnant. It is not known if SKYRIZI can harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if SKYRIZI passes into your breast milk.
  • Become pregnant while taking SKYRIZI. You are encouraged to enroll in the Pregnancy Registry, which is used to collect information about the health of you and your baby. Talk to your healthcare provider or call 1-877-302-2161 to enroll in this registry.

Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of SKYRIZI?
SKYRIZI may cause serious side effects. See "What is the most important information I should know about SKYRIZI?"

Liver problems in Crohn's disease: A person with Crohn's disease who received SKYRIZI through a vein in the arm developed changes in liver blood tests with a rash that led to hospitalization. Your healthcare provider will do blood tests to check your liver before, during, and up to 12 weeks of treatment and may stop treatment with SKYRIZI if you develop liver problems. Tell your healthcare provider right away if you notice any of the following symptoms: unexplained rash, nausea, vomiting, stomach (abdominal) pain, tiredness (fatigue), loss of appetite, yellowing of the skin and eyes (jaundice), and dark urine.

The most common side effects of SKYRIZI in people treated for Crohn's disease include: upper respiratory infections, headache, joint pain, stomach (abdominal) pain, injection site reactions, low red blood cells (anemia), fever, back pain, and urinary tract infection.

The most common side effects of SKYRIZI in people treated for plaque psoriasis and psoriatic arthritis include: upper respiratory infections, headache, feeling tired, injection site reactions, and fungal skin infections.

These are not all the possible side effects of SKYRIZI. Call your doctor for medical advice about side effects.

Use SKYRIZI exactly as your healthcare provider tells you to use it.

SKYRIZI is available in a 150 mg/mL prefilled syringe and pen, a 600 mg/10 mL vial for intravenous infusion, and a 180 mg/1.2 mL or 360 mg/2.4 mL single-dose prefilled cartridge with an on-body injector.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.

Please click here for Full Prescribing Information and Medication Guide for SKYRIZI.

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

About Digestive Disease Week®
Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW is an in-person and online meeting from May 6-9, 2023 . The meeting showcases more than 3,100 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org .

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 2022 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.

US-MULT-230315

References:

  1. RINVOQ (upadacitinib) [Package Insert]. North Chicago, Ill. : AbbVie Inc.
  2. LINZESS (linaclotide) [Package Insert]. North Chicago, Ill. : AbbVie Inc.
  3. SKYRIZI (risankizumab) [Package Insert]. North Chicago, Ill. : AbbVie Inc.

Cision View original content: https://www.prnewswire.com/news-releases/abbvie-releases-new-data-demonstrating-breadth-of-its-gastroenterology-portfolio-at-2023-digestive-disease-week-301817365.html

SOURCE AbbVie

News Provided by PR Newswire via QuoteMedia

ABBV
The Conversation (0)
Health Canada Approves AbbVie's RINVOQ®  for the Treatment of Adults with Active Non-Radiographic Axial Spondyloarthritis

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.

News Provided by Canada Newswire via QuoteMedia

Keep reading...Show less
Sirona Biochem Announces Exclusive Global Licensing Agreement with Allergan Aesthetics

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."

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

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.

Keep reading...Show less

Viemed Announces Acquisition of Majority Interest in HomeMed, Forging Partnership With East Alabama Health

Viemed Healthcare, Inc. (the "Company" or "Viemed") (NASDAQ:VMD), a national leader in respiratory care and technology-enabled home medical equipment services, announced the finalization of its strategic partnership with East Alabama Health ("EAH"), providing Viemed with the controlling interest of East Alabama HomeMed, LLC ("HomeMed"). HomeMed provides home medical equipment services to patients within the EAH network as well as those in the surrounding areas of Eastern Alabama.

"We are thrilled to join forces with the exceptional team at East Alabama Health to deliver best-in-class home medical services to their patients and expand HomeMed's business through the strategic partnership," said Viemed Chief Executive Officer Casey Hoyt. "This marks a significant milestone in our ongoing growth strategy, which includes hospital joint ventures and institutional partnerships. We view this transaction as a blueprint that can be replicated nationwide, enhancing care quality while simultaneously creating value for healthcare systems."

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Hydralyte

Execution of Variation to Facility Agreement with PURE Asset Management, Company to Seek a Sale Transaction

Hydration solutions company The Hydration Pharmaceuticals Company Limited (ASX: HPC) (Hydralyte North America or the Company) advises that today it has signed a variation to its facility agreement with boutique asset manager and existing substantial shareholder PURE Asset Management Pty Ltd as trustee for The Income and Growth Fund (PURE or PURE Asset Management) as previously announced to the market on 17 October 2022 (Original PURE Facility).

Keep reading...Show less

Viemed Healthcare Announces Record 2023 Financial Results

Viemed Healthcare, Inc. (the "Company" or "Viemed") (NASDAQ:VMD), a national leader in respiratory care and technology-enabled home medical equipment services, announced today that it has reported its financial results for the three months and year ended December 31, 2023.

Operational highlights (all dollar amounts are USD):

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Hydralyte

Appendix 4E – Preliminary Final Report

Hydration solutions company, The Hydration Pharmaceuticals Company Limited (ASX: HPC) (“Hydralyte North America” or “the Company”), is pleased to report on its activities and cash flows for the 12 months ending 31 December 2023 (FY2023).

Keep reading...Show less
Hand reaching out to healthcare symbols.

Healthcare Stocks: 5 Biggest Companies in 2024

Healthcare is one of the world's most critical sectors, and healthcare stocks offer an opportunity to invest in companies that are making a difference in people’s lives while also providing a steady stream of returns.

Healthcare companies operate in a highly competitive, highly regulated environment. Often at the forefront of innovation in medicine and healthcare technology, the sector has seen a boom of activity in recent years, driven in part by advancements in technology, namely artificial intelligence, machine learning and quantum computing.

Here the Investing News Network has rounded up the biggest healthcare stocks by market cap. Data was collected using TradingView’s stock screener and was accurate as of February 7, 2024.

Keep reading...Show less
Hydralyte

Q4 FY23 Quarterly Report and Appendix 4C: Net Cash Used in Operating Activities Down 56% YoY to Record Low

Hydration solutions company The Hydration Pharmaceuticals Company Limited (ASX: HPC) (“Hydralyte” or “the Company”) is pleased to provide the following update on its operational and financial performance for the three-month period ended 31 December 2023 (the “quarter”).
Keep reading...Show less

Latest Press Releases

Related News

×