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.

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.