Sage Therapeutics and Biogen Share Update on FDA Advisory Committee for Zuranolone
March 08 2023 - 6:30AM
Business Wire
Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq:
BIIB) announced that the U.S. Food and Drug Administration (FDA)
notified the companies that the agency does not currently plan to
convene an advisory committee meeting to discuss the New Drug
Application (NDA) for zuranolone in the treatment of major
depressive disorder (MDD) and postpartum depression (PPD).
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Zuranolone is an investigational drug being evaluated as a
14-day, rapid-acting, once-daily, oral treatment in adults with MDD
and PPD. The application has been granted priority review and the
FDA has assigned a Prescription Drug User Fee Act (PDUFA) action
date of August 5, 2023.
About ZURANOLONE
Zuranolone (SAGE-217/BIIB125) is a once-daily, 14-day,
investigational drug in development for the treatment of major
depressive disorder (MDD) and postpartum depression (PPD).
Zuranolone is an oral neuroactive steroid (NAS) GABA-A receptor
positive allosteric modulator (PAM). The GABA system is the major
inhibitory signaling pathway of the central nervous system and
contributes to regulating brain function.
Zuranolone is being evaluated in the LANDSCAPE and NEST clinical
development programs. The two development programs include multiple
studies examining use of zuranolone in several thousand people with
a variety of dosing, clinical endpoints, and treatment paradigms.
The LANDSCAPE program includes five studies of zuranolone in people
with MDD (MDD-201B, MOUNTAIN, SHORELINE, WATERFALL, and CORAL
Studies). The NEST program includes two studies of zuranolone in
women with PPD (ROBIN and SKYLARK Studies). Additionally, Shionogi
completed a Phase 2 study of zuranolone in Japan in people with
MDD.
About Sage Therapeutics
Sage Therapeutics is a biopharmaceutical company fearlessly
leading the way to create a world with better brain health. Our
mission is to pioneer solutions to deliver life-changing brain
health medicines, so every person can thrive. For more information,
please visit www.sagerx.com.
About Biogen
Founded in 1978, Biogen is a leading global biotechnology
company that has pioneered multiple breakthrough innovations
including a broad portfolio of medicines to treat multiple
sclerosis, the first approved treatment for spinal muscular
atrophy, and two co-developed treatments to address a defining
pathology of Alzheimer’s disease. Biogen is advancing a pipeline of
potential novel therapies across neurology, neuropsychiatry,
specialized immunology and rare diseases and remains acutely
focused on its purpose of serving humanity through science while
advancing a healthier, more sustainable and equitable world.
We routinely post information that may be important to investors
on our website at www.biogen.com. Follow us on social media -
Twitter, LinkedIn, Facebook, YouTube.
Sage Therapeutics Safe Harbor
Various statements in this release concern Sage's future
expectations, plans and prospects, including without limitation our
statements regarding: the FDA’s plan not to convene an advisory
committee meeting; the potential profile and benefit of zuranolone
in the treatment of MDD and PPD; our expectations regarding the
PDUFA date for our NDA; the potential for approval of zuranolone;
and other statements as to our mission, goals and plans. These
statements constitute forward-looking statements as that term is
defined in the Private Securities Litigation Reform Act of 1995.
These forward-looking statements are neither promises nor
guarantees of future performance, and are subject to a variety of
risks and uncertainties, many of which are beyond our control,
which could cause actual results to differ materially from those
contemplated in these forward-looking statements, including the
risks that: the FDA may decide to convene an advisory committee at
a future date despite its current plan not to hold an advisory
committee meeting; the FDA may find that the data included in our
NDA for zuranolone are not sufficient for approval and may not
approve the NDA or may grant a more narrow or limited approval than
we are seeking; the FDA may require additional trials or data which
may significantly delay and put at risk our efforts to obtain
approval and may not be successful; the FDA may not meet expected
review timelines for our NDA or may extend the review period as a
result of additional or supplemental information we submit or there
may be other delays in such timelines; other decisions or actions
of the FDA may affect our efforts with respect to zuranolone and
our plans, progress or results; results of ongoing or future
studies may impact our ability to obtain approval of zuranolone or
impair the potential profile of zuranolone; unexpected concerns may
arise from additional data, analysis or results from any of our
completed studies; we may encounter adverse events at any stage of
development or use that negatively impact further development or
that require additional nonclinical and clinical work which may not
yield positive results; the clinical profile of zuranolone in the
treatment of MDD or PPD, if approved, may not be as we expect; and
we may encounter technical and other unexpected hurdles which may
delay our timing or change our plans or otherwise negatively impact
our efforts to gain approval of zuranolone as a treatment option
for MDD and PPD or to accomplish other aspects of our mission and
goals; as well as those risks more fully discussed in the section
entitled "Risk Factors" in our most recent quarterly report with
the Securities and Exchange Commission (SEC), as well as
discussions of potential risks, uncertainties, and other important
factors in our subsequent filings with the SEC. In addition, any
forward-looking statements represent our views only as of today and
should not be relied upon as representing our views as of any
subsequent date. We explicitly disclaim any obligation to update
any forward-looking statements.
Biogen Safe Harbor
This news release contains forward-looking statements, including
statements made pursuant to the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995, relating to the
potential, benefits, safety and efficacy of zuranolone; the
potential clinical effects of zuranolone; the clinical development
program for zuranolone; clinical development programs, clinical
trials and data readouts and presentations for zuranolone; the
potential treatment of MDD and PPD; the potential of Biogen’s
commercial business and pipeline programs, including zuranolone;
the anticipated benefits and potential of Biogen’s collaboration
arrangement with Sage; and risks and uncertainties associated with
drug development and commercialization. These forward-looking
statements may be accompanied by words such as “aim,” “anticipate,”
“believe,” “could,” “estimate,” “expect,” “forecast,” “intend,”
“may,” “plan,” “potential,” “possible,” “will,” “would” and other
words and terms of similar meaning. Drug development and
commercialization involve a high degree of risk and only a small
number of research and development programs result in
commercialization of a product. Results in early-stage clinical
trials may not be indicative of full results or results from later
stage or larger scale clinical trials and do not ensure regulatory
approval. You should not place undue reliance on these statements,
or the scientific data presented.
These statements involve risks and uncertainties that could
cause actual results to differ materially from those reflected in
such statements, including without limitation, uncertainty of
success in the development and potential commercialization of
zuranolone; unexpected concerns may arise from additional data,
analysis or results of clinical studies of zuranolone; regulatory
authorities may require additional information or further studies,
or may fail or refuse to approve or may delay approval of Biogen’s
drug candidates, including zuranolone; the occurrence of adverse
safety events; the risks of other unexpected hurdles, costs or
delays; failure to protect and enforce data, intellectual property
and other proprietary rights and uncertainties relating to
intellectual property claims and challenges; product liability
claims; third party collaboration risks; and the direct and
indirect impacts of the ongoing COVID-19 pandemic on our business,
results of operations and financial condition. The foregoing sets
forth many, but not all, of the factors that could cause actual
results to differ from Biogen’s expectations in any forward-looking
statement. Investors should consider this cautionary statement as
well as the risk factors identified in Biogen’s most recent annual
or quarterly report and in other reports Biogen has filed with the
U.S. Securities and Exchange Commission. These statements are based
on Biogen’s current beliefs and expectations and speak only as of
the date of this news release. Biogen does not undertake any
obligation to publicly update any forward-looking statements,
whether as a result of new information, future developments or
otherwise.
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version on businesswire.com: https://www.businesswire.com/news/home/20230307006059/en/
MEDIA: Sage Kathryn Ritzinger +1 646 872-2912
Kathryn.Ritzinger@sagerx.com Biogen Jack Cox + 1 210 544
7920 public.affairs@biogen.com INVESTORS: Sage Helen
Rubinstein +1 315 382-3979 Helen.Rubinstein@sagerx.com
Biogen Mike Hencke +1 781 464 2442 IR@biogen.com
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