FDA+ roundup: Ad­comm date set for Cy­to­ki­net­ics heart drug; New gener­ic drug guid­ance to re­duce fa­cil­i­ty de­lays

The FDA has set Dec. 13 as the day that its Car­dio­vas­cu­lar and Re­nal Drugs Ad­vi­so­ry Com­mit­tee will re­view Cy­to­ki­net­ics’ po­ten­tial heart drug, set­ting up a key vote ahead of a Feb. 28, 2023 PDU­FA date.

The drug, known as ome­cam­tiv mecar­bil, read out its first Phase III in 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 the key to break­ing in­to the mar­ket, fail­ing to sig­nif­i­cant­ly dif­fer in re­duc­ing car­dio­vas­cu­lar death from place­bo.

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.