All Smiles At Sage As Phase III Postpartum Depression Data Are Positive
The company plans to file an NDA with FDA in the first half of 2018 for an intravenous formulation of brexanolone, which could be the first treatment specifically for postpartum depression.
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I.V. Zulresso is the first US FDA-approved drug for postpartum depression (PPD) and Sage's first commercial product – with a list price of $34,000. It will help the company build a presence in PPD as it completes late-stage development for oral candidate SAGE-217.
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.
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