FDA re­jects Cy­to­ki­net­ic­s' heart fail­ure drug, but the biotech has a back­up

The FDA re­ject­ed Cy­to­ki­net­ics’ lead can­di­date for heart fail­ure, say­ing the com­pa­ny didn’t pro­vide enough ev­i­dence of the drug’s ef­fi­ca­cy.

Cy­to­ki­net­ics re­vealed Tues­day that it re­ceived a com­plete re­sponse let­ter from the FDA for ome­cam­tiv mecar­bil to treat heart fail­ure with re­duced ejec­tion frac­tion.

Ac­cord­ing to the com­pa­ny, the FDA de­ter­mined that the Phase III tri­al, GALAC­TIC-HF, was “not suf­fi­cient­ly per­sua­sive to es­tab­lish sub­stan­tial ev­i­dence of ef­fec­tive­ness for re­duc­ing the risk of heart fail­ure events and car­dio­vas­cu­lar death in adults with chron­ic heart fail­ure with re­duced ejec­tion frac­tion.”

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