FDA Panel Approves Sage's Novel Antidepressant for Postnatal Depression, Rejects Alkermes' Treatment

Sage’s Zulresso (brexanolone) is on course for approval for postnatal depression in the US after a positive vote from an FDA advisory committee. The committee voted 17-1 that the benefit-risk profile for Zulresso supported its approval as an injectable therapy for post-partum depression (PPD), provided it is delivered on an inpatient basis by qualified staff in a licensed clinic.

If approved, Zulresso will become the first drug specifically approved for PPD, affecting around 400,000 women annually in the US. The FDA is expected to make a decision by 19 December, with a potential launch in the new year. The panel unanimously agreed on Zulresso's effectiveness in PPD, highlighting its rapid action compared to traditional antidepressants.

Brexanolone, a GABAA receptor modulator, is administered as a 60-hour infusion and has shown to start working within days, sometimes as quickly as 14 hours after dosing. Sage is also exploring the use of brexanolone for the depressive phase of bipolar disorder, with phase II trials planned to start before year-end.

In contrast, Alkermes faced a setback with its antidepressant ALKS 5461, as the advisory committee voted 21-2 against its approval for treatment-resistant major depressive disorder. The committee raised concerns over the drug's benefit-risk profile, trial design, and the use of a novel statistical method. Despite being deemed safe, the panel concluded that Alkermes had not provided sufficient evidence to support the efficacy of ALKS 5461.

The decision on Zulresso not only marks a significant milestone for Sage but also reduces the risk for its follow-up drug, SAGE-217, currently in phase III testing for major depressive disorder. This development has sparked speculation about potential interest from larger companies in Sage's pipeline.