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QULIPTA Now Approved by Health Canada for the Preventive Treatment of Episodic Migraine in Adults

  • QULIPTA is the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) specifically developed for the preventive treatment of episodic migraine.

  • AbbVie is the only pharmaceutical company to offer three treatments across the full spectrum of migraine to help patients living with this debilitating disease .

  ABBVie (NYSE: ABBV) announced today that Health Canada has approved QULIPTA (atogepant) for the prevention of episodic migraine (ABBVie's migraine portfolio to support Canadians impacted by migraine.

AbbVie logo (CNW Group/AbbVie Canada)

"Migraine is one of the leading causes of disability in Canada and impacts a person's ability to function and perform their daily routines," says Dr. Elizabeth Leroux , Founder and Chair, Migraine Canada. "People with migraine face incredible challenges managing a debilitating neurological condition that others cannot see or truly understand. Migraine Canada welcomes the approval of QULIPTA for Canadians who will now have an opportunity to experience a new treatment that will help prevent and manage episodic migraine appropriately and take control of their migraine attacks before they even start."

The approval is supported by data from a robust clinical program evaluating the efficacy, safety and tolerability of QULIPTA in nearly 2,000 patients who experienced 4 to 14 migraine days per month. QULIPTA demonstrated statistically significant, clinically meaningful, rapid and continuous reductions in mean monthly migraine days among adults with episodic migraine compared to placebo across the 12-week treatment period with significant reductions seen in weeks 1-4. 1

"AbbVie is committed to bringing new innovative treatments to address the needs of Canadians living with migraine," says Tracey Ramsay , Vice President and General Manager, AbbVie Canada. "With the approval of QULIPTA for the preventive treatment of episodic migraine, AbbVie has expanded on our support to those living with migraine given the legacy of BOTOX ® for the treatment of chronic migraine, and recently approved UBRELVY ® for acute treatment of migraine. AbbVie is proud to partner with the migraine community to advance treatment and care for people living with this neurological disease."

About Migraine

Migraine is a complex neurological disease with recurrent attacks that lasts 4-72 hours. It can be defined by symptoms such as moderate to severe pain intensity, nausea, vomiting, photophobia and phonophobia. 2 An estimated 2.7 million Canadians are reported diagnosed with migraine, however the number of people living with migraine is much higher. 3 Episodic migraine is characterized as having less than 15 headache days per month, while 15 headache days or more per month, is considered chronic. 4

About QULIPTA (atogepant)

QULIPTA (atogepant) is the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) specifically developed for the preventive treatment of episodic migraine. QULIPTA is an orally administered, small molecule, selective calcitonin gene-related peptide (CGRP) receptor antagonist that blocks the binding of the CGRP to its receptor. CGRP is a neuropeptide that may play a role in migraine pathophysiology. 1

For important safety information, please consult the QULIPTA™ Product Monograph at www.abbvie.ca .

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 its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.ca . Follow AbbVie Canada on Twitter , on Instagram or find us on LinkedIn.

For more information on AbbVie's complete migraine portfolio, please visit www.abbvie.ca.

______________________________

1

AbbVie Canada. QULIPTA Product Monograph. December 2022.

2

Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018;38(1):1-211. Accessed April 2022.

3

Ramage-Morin P., & Gilmour, H. (2014). Prevalence of migraine in the Canadian household population. Health Reports, 25(6): 10-16. https://www150.statcan.gc.ca/n1/en/pub/82-003-x/2014006/article/14033-eng.pdf?st=CSyp19VF . Accessed April 2022.

4

Migraine Canada. The Migraine Family: categories and groups. Retrieved from https://migrainecanada.org/posts/the-migraine-tree/roots/migraine-categories/the-migraine-family-categories-and-groups/ . Accessed April 2022.

SOURCE AbbVie Canada

Cision View original content to download multimedia: http://www.newswire.ca/en/releases/archive/January2023/09/c4650.html

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ABBV
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."

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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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Aurinia Pharmaceuticals to Release Fourth Quarter and Full Year Financial and Operational Results on February 28, 2023

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) today announced that it will release financial and operational results for fourth quarter and full year 2023 on Tuesday, February 28, 2023, before markets open. Aurinia's management team will host a conference call/webcast at 8:30 am ET that day to review these results and provide a general business update. Interested participants can dial 877-407-9170 (Toll-free U.S. & Canada). The audio webcast can also be accessed under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com . A replay of the audio webcast will be available on Aurinia's website.

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Komo Doubles Retail Distribution to 840 Stores

Komo Doubles Retail Distribution to 840 Stores

Komo Plant Based Foods Inc. (CSE: YUM) (OTCQB: KOMOF) (FSE: 9HB0) (the "Company", "Komo"), a premium plant‐based food company, reports significant growth in the number of retail stores carrying Komo products with an increase of over 100% in 3 months.

Komo Plant Based Foods Inc., a fast-growing plant-based food products manufacturer, announces a 100% increase in retail distribution since November of 2022, now available in 840 grocery retail locations across Canada. This impressive growth includes Loblaw's and Loblaws' banner stores and the addition of 50 new retail stores in January 2023, including Georgia Main Group (IGA West and Fresh St. Market), Sobey's West, Safeway and Freson Brothers locations in western Canada, and key natural accounts such as Boites à Grain in Quebec.

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Komo Plant-Based Foods Inc.

Komo Plant-Based Foods Announces Private Placement Financing

Komo Plant Based Foods Inc. (CSE: YUM) (OTCQB: KOMOF) (FRA:9HB) ("Komo" or the "Company"), a premium plant-based food company, announces a non-brokered private placement of units of the Company (the "Units") at a price of $0.15 per Unit for gross proceeds of up to $500,000 (the "Offering"). Each Unit consists of one common share of the Company (each, a "Share") and one common share purchase warrant (each, a "Warrant"). Each Warrant is exercisable to acquire one common share of the Company (a "Warrant Share") at a price of $0.20 per Warrant Share for a period of 36 months from the closing of the Offering.

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U.S. FDA Approves Trodelvy® in Pre-treated HR+/HER2- Metastatic Breast Cancer

-- First Trop-2 Directed ADC to Demonstrate Overall Survival Benefit in HR+/HER2- Metastatic Breast Cancer Patients who had Received Prior Endocrine-based Therapy and at Least Two Chemotherapies --

-- Trodelvy has Now Improved Survival in both Pre-Treated HR+/HER2- Metastatic Breast Cancer and in Second-Line Metastatic Triple-Negative Breast Cancer --

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Bristol Myers Squibb to Participate in the Guggenheim Healthcare Talks 2023 Oncology Conference

Bristol Myers Squibb (NYSE: BMY) today announced that the company will take part in a fireside chat at the Guggenheim Healthcare Talks 2023 Oncology Conference on Thursday, February 9, 2023. Chris Boerner , Ph.D., Executive Vice President, Chief Commercialization Officer, will answer questions about the company at 1:00 p.m. ET.

Investors and the general public are invited to listen to a live webcast of the session at http://investor.bms.com . An archived edition of the session will be available later that day.

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Gilead Sciences Announces 2.7 Percent Increase in First Quarter 2023 Dividend

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the company's Board of Directors has declared an increase of 2.7% in the company's quarterly cash dividend, beginning in the first quarter of 2023. The increase will result in a quarterly dividend of $0.75 per share of common stock. The dividend is payable on March 30, 2023, to stockholders of record at the close of business on March 15, 2023. Future dividends will be subject to Board approval.

About Gilead Sciences

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