FDA ad­comm votes 8-3 against Cy­to­ki­net­ic­s' po­ten­tial heart fail­ure drug

Af­ter more than a decade and a half in de­vel­op­ment, the FDA’s Car­dio­vas­cu­lar and Re­nal Drugs Ad­vi­so­ry Com­mit­tee to­day vot­ed 8-3 against ap­proval of Cy­to­ki­net­ics’ heart fail­ure drug.

Ad­comm mem­bers said the drug’s po­ten­tial ben­e­fits did not seem to out­weigh its risks, with pan­el mem­bers rais­ing con­cerns about the drug’s safe­ty and its lim­it­ed ef­fi­ca­cy.

The drug, known as ome­cam­tiv mecar­bil (OM), has seen mixed clin­i­cal re­sults, with a first Phase III read­out from No­vem­ber 2020 hit­ting the pri­ma­ry end­point of re­duc­ing the odds of hos­pi­tal­iza­tion or oth­er ur­gent care for heart fail­ure by 8%. But it al­so missed a key sec­ondary end­point an­a­lysts had pegged as key to break­ing in­to the mar­ket.

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