Biogen and Sage Therapeutics’ Zurzuvae (zuranolone) Receive the US FDA’s Approval for Women with Postpartum Depression
Shots:
- The US FDA has approved Zurzuvae (50mg) in adults with PPD. The product is expected to be commercially available in Q4’23
- The approval was based on the results from the (NEST) clinical development program incl. two studies (ROBIN) and (SKYLARK) evaluating Zurzuvae vs PBO in adult women with PPD. Both studies met their 1EPs & showed a significant mean reduction from baseline in the 17-item HAMD-17 total score on Day 15
- The (SKYLARK) study met 2EPs with a significant reduction in depressive symptoms seen as early as Day 3 and sustained through Day 45, was well-tolerated with a consistent safety profile. The US FDA has issued a CRL for zuranolone’s NDA to treat MDD
Ref: Biogen | Image: Biogen
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
