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.
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