PDUFA goal date extended to March 19, 2019 to finalize REMS
No additional clinical data or information requested by the FDA
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 20, 2018--
Sage Therapeutics, Inc. (NASDAQ: SAGE), a clinical-stage
biopharmaceutical company developing novel medicines to treat
life-altering central nervous system (CNS) disorders, today announced
that the U.S. Food and Drug Administration (FDA) has extended the
Prescription Drug User Fee Act (PDUFA) date for its Priority Review of
the New Drug Application (NDA) for ZULRESSO™ (brexanolone) injection for
the treatment of postpartum depression (PPD). The previously disclosed
December 19, 2018 PDUFA goal date has been extended by a period of three
months to March 19, 2019.
After the recent positive FDA Advisory Committee meeting, Sage submitted
a proposed Risk Evaluation and Mitigation Strategies (REMS) program with
Elements to Ensure Safe Use (ETASU) in response to the FDA’s request.
Under PDUFA VI, FDA can elect to extend the PDUFA goal date by three
months for submission of a REMS with ETASU not submitted in the original
NDA, and FDA has elected to do so. The FDA has not requested any
additional clinical data or any additional information from the Company
as part of the extension.
“Our primary goal remains bringing treatment to women suffering from PPD
as quickly as possible. In light of this unexpected delay, we will work
diligently with the FDA to ensure that the unmet medical need of women
suffering with PPD can be addressed expeditiously,” said Jeff Jonas,
M.D., chief executive officer of Sage.
If approved, ZULRESSO is expected to be scheduled by the U.S. Drug
Enforcement Administration (DEA), consistent with other approved
GABAergic therapies. The DEA is required to issue an interim final rule
controlling the drug within 90 days of approval. Preparations continue
for a potential U.S. commercial launch of ZULRESSO for the treatment of
PPD, which is now planned for June 2019, if the NDA is approved and
post-DEA scheduling.
ZULRESSO has been granted Breakthrough Therapy Designation and is the
first medicine under FDA review specifically for the treatment of PPD,
the most common medical complication of childbirth. It is estimated that
PPD affects approximately one in nine women who have given birth in the
U.S. and 400,000 women annually. Symptoms of PPD may include sadness,
anxiety, irritability, withdrawing from friends or family, having
trouble bonding with her baby and thinking about harming herself or,
more rarely, her baby.
On November 2, 2018, the FDA Psychopharmacologic Drugs Advisory
Committee (PDAC) and Drug Safety and Risk Management Advisory Committee
(DSaRM) jointly voted (17 yes, 1 no) that data support the favorable
benefit-risk profile of ZULRESSO for the treatment of PPD when
administered by qualified staff in a facility that has been certified
under a REMS program. The committees based their joint recommendation on
the safety and efficacy data from three placebo-controlled clinical
studies.
About Postpartum Depression
Postpartum 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. Postpartum depression is estimated to affect
approximately one in nine women who have given birth in the U.S. and
400,000 women annually. More than half of these cases may go undiagnosed
without proper screening. There are no FDA approved therapies
specifically indicated for PPD and there is a high unmet medical need
for improved pharmacological therapy in PPD.
About ZULRESSOTM (brexanolone) Injection
Brexanolone
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. ZULRESSOTM
(brexanolone) injection has completed Phase 3 clinical development for
postpartum depression and a New Drug Application is currently under
review with the U.S. Food and Drug Administration. ZULRESSO for the
treatment of PPD has been granted Breakthrough Therapy Designation by
the FDA and PRIority MEdicines (PRIME) designation from the European
Medicines Agency (EMA). The FDA has conditionally accepted the
proprietary name ZULRESSO for Sage’s intravenous formulation of
brexanolone.
About Sage Therapeutics
Sage Therapeutics is a
clinical-stage biopharmaceutical company committed to developing novel
medicines to transform the lives of patients with life-altering CNS
disorders. Sage's lead product candidate, ZULRESSO™ (brexanolone)
injection, has completed Phase 3 clinical development for postpartum
depression and a New Drug Application is currently under review with the
U.S. Food and Drug Administration. Sage is developing a portfolio of
novel product candidates targeting critical CNS receptor systems,
including SAGE-217, which is in Phase 3 development in major depressive
disorder and postpartum depression. For more information, please visit www.sagerx.com.
Forward-Looking Statements
Various statements in this release concern Sage's future
expectations, plans and prospects, including without limitation
statements regarding: our expectations regarding the possible approval
of our NDA filing for ZULRESSO™ (brexanolone) injection; the potential
for ZULRESSO to be the first medication specifically indicated for PPD;
our estimates of the prevalence of PPD; and other statements regarding
our business and 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 not agree with the recommendations of the joint
Advisory Committee, and, despite the recommendation, may determine that
the clinical and non-clinical data we have generated to date are
insufficient to gain regulatory approval to launch and commercialize our
product in PPD or may determine that additional trials or data are
necessary in order to obtain approval; the FDA may not complete its
review of our filing within the target timelines; the actual size of the
PPD patient population may be significantly lower than our estimates
and, even if ZULRESSO is successfully approved for PPD, it may only be
used to treat a subset of the PPD population, particularly given the
intravenous (IV) mode of administration, limitations on site of
administration to a certified healthcare facility monitored by a
qualified healthcare provider, and the necessity for a REMS; we may
encounter unexpected safety, tolerability or other issues with ZULRESSO
in ongoing clinical trials or in commercial use, if approved; 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 of
any of our product candidates 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 Quarterly Report on Form 10-Q, 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20181120005168/en/
Source: Sage Therapeutics, Inc.
Investor Contact:
Paul Cox
617-299-8377
paul.cox@sagerx.com
Media Contact:
Maureen L. Suda
585-355-1134
maureen.suda@sagerx.com
