De­spite flop­ping piv­otal tri­al, No­var­tis' En­tresto will face ad­comm fir­ing line for holy grail heart fail­ure pa­tients

No­var­tis had big ideas for its heart-fail­ure mar­ket leader En­tresto in a high­ly sought-af­ter pa­tient pop­u­la­tion be­fore a Phase III flop de­railed its plans. But the Swiss drug­mak­er al­ways held out hope En­tresto would make a quick come­back, and with the FDA’s back­ing next week it could be right on the verge of do­ing so.

An FDA ad­vi­so­ry com­mit­tee on Tues­day will scru­ti­nize No­var­tis’ ap­pli­ca­tion to pit En­tresto against chron­ic heart fail­ure pa­tients with a pre­served ejec­tion frac­tion (HF­pEF), an in­di­ca­tion with­out an ap­proved ther­a­py and one that could spell $5 bil­lion in sales per year.

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