Sage Impresses With Second Postpartum Depression Therapy
Positive top-line Phase III data with Sage's second lead positive allosteric modulator at GABA receptors, SAGE-217, in postpartum depression continues to back the US biotech's approach to the devastating condition.
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Sage Therapeutics points to patient compliance and selection as factors in its failed trial of SAGE-217. The company sees positive implications in the data as it waits for other SAGE-217 studies.
Committee overwhelmingly supports approval for treatment-resistant depression but warns that pricing and combination therapy indication could hinder patient access. Esketamine’s risks of sedation and dissociative effects, and its abuse potential, will necessitate a strict risk management strategy.
After an advisory committee recommended approval for the postpartum depression treatment if administered under a REMS program at certified centers, Sage submitted a proposed REMS, causing the agency to extend the PDUFA date three months.