No­var­tis' En­tresto, fac­ing a big come­back in hard-to-treat heart fail­ure pa­tients, scores FDA nod af­ter ad­comm cake­walk

Hard-and-fast rules in drug de­vel­op­ment are hard to come by, but one has long been the stan­dard for mar­ket ap­provals — you have to hit your pri­ma­ry end­points in piv­otal stud­ies. But for No­var­tis’ heart fail­ure med En­tresto, what’s a Phase III miss be­tween friends?

The FDA on Tues­day ap­proved En­tresto, a com­bi­na­tion of neprilysin in­hibitor sacu­bi­tril and an­giotensin re­cep­tor II block­er val­sar­tan, to treat heart fail­ure pa­tients with a pre­served ejec­tion frac­tion (HF­pEF), mak­ing it the first drug on the mar­ket for that pop­u­la­tion.

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