CAMBRIDGE, Mass. & NORTH CHICAGO, Ill.--(BUSINESS WIRE)--Today Biogen (NASDAQ: BIIB) and AbbVie (NYSE: ABBV) announced that the U.S. Food and Drug Administration (FDA) has accepted for review the companies’ Biologics License Application (BLA) requesting marketing approval of ZINBRYTA™ (daclizumab high-yield process) for relapsing forms of multiple sclerosis (MS).
“We are pleased by the FDA’s acceptance of our BLA for ZINBRYTA, which we believe has the potential to help people living with MS,” said Gilmore O’Neill, vice president, Multiple Sclerosis Research and Development at Biogen. “We look forward to working with both U.S. and European regulatory authorities to bring this investigational treatment to MS patients as soon as possible.”
Biogen and AbbVie announced in March 2015 that their Marketing Authorisation Application for ZINBRYTA was validated by the European Medicines Agency for review in the European Union.
The BLA included results from two pivotal trials, DECIDE and SELECT, in which ZINBRYTA 150 mg was administered subcutaneously every four weeks in people with relapsing-remitting MS.
“This is an important milestone in the development program for ZINBRYTA and moves us a step closer to potentially bringing a new treatment option to patients with MS,” said Michael Severino, M.D., executive vice president, Research and Development and Chief Scientific Officer at AbbVie.
About ZINBRYTA™ (daclizumab high-yield process)
ZINBRYTA
(daclizumab high-yield process) is an investigational treatment and 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 abnormally activated in
MS. ZINBRYTA modulates IL-2 signaling without causing general immune
cell depletion. ZINBRYTA is believed to work by decreasing
abnormally-activated T-cells and pro-inflammatory lymphoid tissue
inducer cells, and increasing CD56bright natural killer (NK)
cells, important cells that help regulate the immune system.
Biogen and AbbVie are jointly developing ZINBRYTA.
About Biogen
Through cutting-edge science and medicine,
Biogen discovers, develops and delivers to patients worldwide innovative
therapies for the treatment of neurodegenerative diseases, hematologic
conditions and autoimmune disorders. 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 product labeling, press releases and
additional information about the company, please visit www.biogen.com.
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forward-looking statements, including statements about the potential
impact of ZINBRYTA, if approved. These statements may be identified by
words such as "believe," "expect," "may," "plan," "potential," "will"
and similar expressions, and are based on our current beliefs and
expectations. 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
unexpected concerns may arise from additional data or analysis,
regulatory authorities may require additional information or further
studies, or may fail to approve or may delay approval of our drug
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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. AbbVie employs more than 26,000 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.
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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
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but are not limited to, challenges to intellectual property, competition
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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
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developments, except as required by law.
