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Sage Therapeutics Receives Notification of PDUFA Extension for ZULRESSO (brexanolone) Injection 

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CAMBRIDGE, Mass., November 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 FDAs 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. …

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Source: US SEC
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8-K_for_Sage_Therapeutics_Inc_8-K-11-20-2018