FDA moves Sage’s post­par­tum de­pres­sion drug brex­anolone in­to reg­u­la­tors’ busy pri­or­i­ty lane

The FDA’s pri­or­i­ty re­view path­way is get­ting a work­out. 

Reg­u­la­tors agreed to give Sage Ther­a­peu­tics $SAGE a quick 6-month re­view for IV brex­anolone (SAGE-547) — the FDA’s third pri­or­i­ty move in two days — which it hopes will go on to be­come its first mar­ket­ed drug. And this one could be head­ed to a huge mar­ket, if the FDA ap­proves it for post­par­tum de­pres­sion, a con­di­tion that af­flicts a sig­nif­i­cant mi­nor­i­ty of women af­ter giv­ing birth.

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.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER