EXHIBIT 99.1
Sage Therapeutics Announces FDA Advisory Committee Votes17-1 in Support of Benefit-Risk Profile of ZULRESSO™ (brexanolone) Injection for Treatment of Postpartum Depression
If approved, ZULRESSO would be the first medicine specifically indicated for the treatment of postpartum depression (PPD)
CAMBRIDGE, Mass. Nov. 2, 2018 – 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 dialing1-866-450-8683 (toll-free domestic) or1-281-542-4847 (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 ZULRESSO™ (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
