CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sage Therapeutics (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) 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™ (brexanolone) injection for the treatment of postpartum depression (PPD) when administered by qualified staff in a facility that has been certified under a Risk Evaluation and Mitigation Strategies (REMS) program. The committees based their joint recommendation on the safety and efficacy data from three placebo-controlled clinical studies.
“We are pleased the FDA Advisory Committee agreed that the benefit/risk profile of ZULRESSO supports this novel approach to treating PPD, reflecting the need for an innovative treatment option that may rapidly alleviate suffering for women with PPD and their families,” said Jeff Jonas, M.D., chief executive officer of Sage. “This is another step forward in Sage’s effort to maximize patient benefit by bringing game-changing new treatments to the market.”
ZULRESSO 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.
Sage will further discuss the advisory committee’s outcome during the company’s next financial results conference call on November 6, 2018 at 8:00 AM ET. The live webcast can be accessed on the investor page of Sage's website at investor.sagerx.com. The conference call can be accessed by dialing 1-866-450-8683 (toll-free domestic) or 1-281-542-4847 (international) and using the conference ID 1891169. A replay of the webcast will be available on Sage's website approximately two hours after the completion of the event and will be archived for up to 30 days.
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, 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. 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; the potential impact of
ZULRESSO as a treatment option for PPD, if approved; 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.