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.
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.