Sage ap­pears set for a break­through FDA OK on post­par­tum de­pres­sion drug, but who’s go­ing to use it?

Sage can start this week with a fair­ly firm idea on the time­line for its ini­tial trans­for­ma­tion in­to a mar­ket­ing op­er­a­tion, with the FDA and its out­side ex­perts ap­pear­ing to bless their land­mark drug brex­anolone for post­par­tum de­pres­sion. What they don’t know is who is go­ing to buy it.

The FDA’s ex­pert pan­el vot­ed to back the drug’s risk/ben­e­fit pro­file by a wide mar­gin, 17 in fa­vor and on­ly 1 against, with sev­er­al of the votes cast with an en­thu­si­as­tic en­dorse­ment for the po­ten­tial here. Com­ing in the wake of an up­beat in­ter­nal as­sess­ment at the agency, the writ­ing ap­pears to be on the wall for an OK by the De­cem­ber 19 PDU­FA date.

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