Regulatory

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.

Jeff Jonas, Sage

Jeff Jonas, Sage CEO

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.

The biotech recruited 226 patients for its two pivotal studies for an ailment that afflicts huge numbers of women each year. Typically a disease like PPD would involve large numbers of patients in search of two positive outcomes, but Sage believes it’s right on track to break new ground and score a major OK.

Analysts have pegged peak annual sales at around $400 million to $650 million.

The drug scored a 17.7-point mean reduction for the high dose and a 19.9-point improvement for the low dose in the first study for severe PPD compared to 14 points in the placebo arm. In study two there was a 14.2-point vs 12-point difference in the moderate PPD group.


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