Ahead of ad­comm, FDA rais­es un­cer­tain­ties on ben­e­fit-risk pro­file of Cy­to­ki­net­ic­s' po­ten­tial heart drug

The FDA’s Car­dio­vas­cu­lar and Re­nal Drugs Ad­vi­so­ry Com­mit­tee will meet next Tues­day to dis­cuss whether Cy­to­ki­net­ics’ po­ten­tial heart drug can safe­ly re­duce the risk of car­dio­vas­cu­lar death and heart fail­ure in pa­tients with symp­to­matic chron­ic heart fail­ure with re­duced ejec­tion frac­tion.

The drug, known as ome­cam­tiv mecar­bil and in de­vel­op­ment for more than 15 years, has seen mixed 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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