• The new PDUFA date is March 19, 2019
• The FDA has not requested any additional clinical data or any additional information from the Company as part of the extension

Sage Therapeutics announced on 11/20/19 that the 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.

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. 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. 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.