No­var­tis earns ad­com­m's vote of sup­port in come­back FDA re­view for En­tresto in sought-af­ter heart fail­ure pa­tients

No­var­tis’ En­tresto once seemed left for dead in its pur­suit of a set of holy-grail heart fail­ure pa­tients, but the FDA turned the tide af­ter loud­ly sup­port­ing the drug’s ef­fect there. Un­like the ad­u­canum­ab de­ba­cle from last month, an ad­vi­so­ry com­mit­tee has agreed with the FDA’s ar­gu­ment and will send En­tresto ahead to a ma­jor re­view.

An FDA ad­comm on Tues­day gave its over­whelm­ing rec­om­men­da­tion for the agency to ap­prove No­var­tis’ En­tresto, a com­bi­na­tion of sacu­bi­tril and val­sar­tan, to treat cer­tain heart fail­ure pa­tients with a pre­served ejec­tion frac­tion (HF­pEF), an in­di­ca­tion with­out any cur­rent ther­a­pies.

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.