Jim Doherty, Sage Therapeutics chief development officer

FDA says no ad­comm planned for Bio­gen, Sage's de­pres­sion drug

The FDA will not re­quire Bio­gen and Sage Ther­a­peu­tics’ new de­pres­sion drug to go be­fore an ad­vi­so­ry com­mit­tee, the com­pa­nies said Wednes­day morn­ing.

The drug, known as zu­ra­nolone, is de­signed to be a rapid-act­ing treat­ment for se­vere de­pres­sive episodes in pa­tients with ma­jor de­pres­sive dis­or­der and post­par­tum de­pres­sion. Pa­tients take the oral drug once per day for two weeks.

Sage’s chief de­vel­op­ment of­fi­cer Jim Do­her­ty told End­points News that be­fore this morn­ing, the com­pa­ny had not heard from the agency whether an ad­comm was go­ing to be re­quired.

Endpoints News

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