In­ter­cep­t's NASH de­ci­sion date is de­ferred; EMA in­ves­ti­gates safe­ty of LEO Phar­ma gel

→ The first drug­mak­er tipped to win ap­proval for a NASH ther­a­peu­tic is go­ing to have to wait three months longer. The FDA is now ex­pect­ed to make its fi­nal de­ci­sion on In­ter­cept Phar­ma­ceu­ti­cals‘ obeti­cholic acid by June 26. The de­lay was at­trib­uted to a ma­jor amend­ment — ad­di­tion­al in­for­ma­tion was pro­vid­ed by the com­pa­ny in re­sponse to FDA re­quests — as well as to ac­com­mo­date an ad­vi­so­ry com­mit­tee meet­ing, In­ter­cept said in a fil­ing on Fri­day. Last month, the FDA no­ti­fied the com­pa­ny it ten­ta­tive­ly in­tend­ed to hold the ad­comm on April 22 — so a de­lay to the March PDU­FA was in any case ex­pect­ed.

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