Sage files for an approval for its ‘breakthrough’ therapy for postpartum depression
Sage Therapeutics $SAGE is rolling the dice on their “breakthrough” drug for postpartum depression.
The Cambridge, MA-based biotech has filed for an FDA approval of brexanolone IV, pitching the therapy in a shot at its first ever marketed drug after gaining the breakthrough drug pathway from both the FDA and the EMA.
Sage has fielded positive data from two small late-stage studies of a drug aimed at a major market which involves 10% to 20% of all mothers giving birth in any given year. But it also requires a 60-hour infusion period, raising a remarkably high hurdle to adoption. Some analysts believe that this will require a home infusion kit to make it work commercially, though Sage also has a pill form of the drug it’s pushing in the clinic.
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