Sage Therapeutics Submits New Drug Application to U.S. FDA for Intravenous Brexanolone in the Treatment of Postpartum Depress...
April 23 2018 - 7:00AM
Business Wire
Brexanolone IV submission is the Company’s
first New Drug Application
Sage Therapeutics (NASDAQ: SAGE), a clinical-stage
biopharmaceutical company developing novel medicines to treat
life-altering central nervous system (CNS) disorders, today
announced the Company has submitted a New Drug Application (NDA) to
the U.S. Food and Drug Administration (FDA) for its lead product
candidate, an intravenous formulation of brexanolone (SAGE-547),
for the treatment of postpartum depression (PPD).
Brexanolone IV received Breakthrough Therapy Designation in
September 2016, underscoring the significant unmet need in women
with PPD. Breakthrough Therapy Designation is intended to offer a
potentially expedited development path and review for promising
drug candidates intended to treat serious conditions, including
increased interaction and guidance from the FDA.
The NDA submission is supported by data from the Hummingbird
Program. This clinical program included three multicenter,
randomized, double-blind, parallel-group, placebo-controlled trials
(Study 202A, Study 202B and Study 202C), each designed to evaluate
the safety and effectiveness of brexanolone in women with moderate
or severe PPD, aged between 18 and 45 years who were ≤6 months
postpartum at screening in the United States.
About FDA Breakthrough Therapy DesignationThe FDA's
Breakthrough Therapy Designation is intended to expedite the
development and review of a drug candidate that is planned for use,
alone or in combination with one or more other drugs, to treat a
serious or life-threatening disease or condition when preliminary
clinical evidence indicates that the drug may demonstrate
substantial improvement over existing therapies on one or more
clinically significant endpoints. The benefits of Breakthrough
Therapy Designation include the same benefits as Fast Track
Designation, plus an organizational commitment involving the FDA's
senior managers with more intensive guidance from the FDA.
Breakthrough Therapy Designation does not change the standards for
approval.
About Postpartum DepressionPostpartum depression (PPD) is
a distinct and readily identified major depressive disorder that is
the most common medical complication of childbirth, affecting a
subset of women typically commencing in the third trimester of
pregnancy or within four weeks after giving birth. PPD may have
devastating consequences for a woman and for her family, which may
include significant functional impairment, depressed mood and/or
loss of interest in her newborn, and associated symptoms of
depression such as loss of appetite, difficulty sleeping, motor
challenges, lack of concentration, loss of energy and poor
self-esteem. Suicide is the leading cause of maternal death
following childbirth. In the U.S., estimates of new mothers
identified with PPD each year vary by state from 8 to 20 percent,
with an overall average of 11.5 percent. More than half of these
cases may go undiagnosed without proper screening. There are no FDA
approved therapies for PPD and there is a high unmet medical need
for improved pharmacological therapy in PPD.
About Brexanolone (SAGE-547)Brexanolone (SAGE-547) is an
allosteric modulator of both synaptic and extrasynaptic
GABAA receptors. Allosteric modulation of neurotransmitter
receptor activity results in varying degrees of desired activity
rather than complete activation or inhibition of the receptor.
Sage’s proprietary intravenous (IV) formulation of brexanolone is
being developed for the treatment of postpartum depression (PPD)
and has been granted Breakthrough Therapy Designation by
the FDA and PRIority MEdicines (PRIME) designation from
the European Medicines Agency (EMA) in PPD.
About Sage TherapeuticsSage Therapeutics is a
clinical-stage biopharmaceutical company committed to developing
novel medicines to transform the lives of patients with
life-altering central nervous system (CNS) disorders. Sage has a
portfolio of novel product candidates targeting critical CNS
receptor systems, GABA and NMDA. Sage's lead program, a proprietary
IV formulation of brexanolone (SAGE-547), has completed Phase 3
clinical development for postpartum depression. Sage is developing
its next generation modulators, including SAGE-217 and SAGE-718, in
various CNS disorders. For more information, please visit
www.sagerx.com.
Forward-Looking StatementsVarious statements in this
release concern Sage's future expectations, plans and prospects,
including without limitation our statements regarding or implying:
the potential for approval of brexanolone IV in the treatment of
PPD; the potential for expedited development and review of
brexanolone IV in PPD as a result of the Breakthrough Therapy
Designation from the FDA; our expectations regarding the possible
acceptance of our NDA filing; our estimates of the prevalence of
PPD; and our view as to the potential for brexanolone IV and the
other product candidates in our portfolio. 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 not to accept for filing our NDA for brexanolone IV
in PPD; the clinical and non-clinical data we have generated with
our proprietary formulation of brexanolone to date may be
determined by the FDA, despite prior advice, to be insufficient to
file for or gain regulatory approval to launch and commercialize
our product in PPD and the FDA may determine that additional trials
or data are necessary in order to file for or obtain approval; the
FDA may find fault with the data generated at particular clinical
site or sites or with the activities of our trial monitor or may
disagree with our analyses of the results of our trials or identify
issues with our manufacturing or quality systems, and any such
findings or issues could require additional data or analyses or
changes to our systems that could delay or prevent us from gaining
approval of brexanolone IV; we may not achieve expedited
development or review of brexanolone IV as a result of the
Breakthrough Therapy Designation from the FDA; the actual size of
the PPD patient population may be significantly lower than our
estimates and, even if brexanolone IV is successfully approved for
PPD, it may only be approved or used to treat a subset of the PPD
population; we may encounter unexpected safety or tolerability
issues with brexanolone IV in ongoing clinical trials; we may not
be able to successfully demonstrate the efficacy and safety of any
of our other product candidates at each stage of development;
success in early stage clinical trials may not be repeated or
observed in ongoing or future studies of our product candidates;
ongoing and future clinical results may not support further
development or be sufficient to gain regulatory approval to market
our product candidates; and we may encounter technical and other
unexpected hurdles in the development and manufacture of our
product candidates; as well as those risks more fully discussed in
the section entitled "Risk Factors" in our most recent Annual
Report on Form 10-K, and discussions of potential risks,
uncertainties, and other important factors in our subsequent
filings with the Securities and Exchange Commission. 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20180423005160/en/
Sage TherapeuticsInvestor Contact:Paul Cox,
617-299-8377paul.cox@sagerx.comorMedia Contact:Maureen L.
Suda, 585-355-1134maureen.suda@sagerx.com
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