[April 29, 2015] |
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FDA Accepts Biologics License Application For ZINBRYTA (Daclizumab High-Yield Process) For Treatment of MS
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 disovers, 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.
Biogen Safe Harbor This press release contains
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
candidates, or we may encounter other unexpected hurdles. 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. 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.
Follow @abbvie on
Twitter (News - Alert) 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.
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