Sage Reports Voting Results from FDA Advisory Committees for Zulresso (brexanolone) to Treat Postpartum Depression (PPD)

 Sage Reports Voting Results from FDA Advisory Committees for Zulresso (brexanolone) to Treat Postpartum Depression (PPD)

Sage Reports Voting Results from FDA Advisory Committees for Zulresso (brexanolone) to Treat Postpartum Depression (PPD)

Shots:

  • FDA’s PDAC & DSaRM has jointly voted (17yes -1 no) for no favorable risk profile of Zulresso for PPD patients
  • The positive voting results for Zulresso is in response of collective data from three PBO based studies, testing safety & efficacy. The P-III trial for Zulresso is completed with NDA submission, under review by FDA
  • Zulresso IV is an allosteric modulator of both synaptic and extrasynaptic GABAA receptors, also received BT & PRIME designations from EMA

Click here to read full press release/ article | Ref: Sage Therapeutics| Image: Marketing91

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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