Ahead of FDA fil­ing, Sage and Bio­gen tout more da­ta in hopes of al­le­vi­at­ing dura­bil­i­ty con­cerns

With an FDA fil­ing rolling for zu­ra­nolone, Sage and Bio­gen are bring­ing more da­ta on how the drug works in an open-la­bel study.

The part­ners re­port­ed that out of pa­tients with ma­jor de­pres­sive dis­or­der who re­spond­ed to the first round of treat­ment, the me­di­an time to an­oth­er episode re­quir­ing re­peat treat­ment was 135 days for those who got 30 mg of zu­ra­nolone and 249 days for those who got 50 mg. The da­ta come as ques­tions about the dura­bil­i­ty of zu­ra­nolone fol­lowed its two ran­dom­ized tri­al read­outs.

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