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
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