No­var­tis files an­oth­er FDA pe­ti­tion to halt En­tresto com­pe­ti­tion as block­buster fight ap­proach­es

With promis­es of $5 bil­lion-plus in peak sales for No­var­tis’ En­tresto, the Swiss phar­ma is now pe­ti­tion­ing the FDA for a sec­ond time, hop­ing to stave off gener­ic ver­sions for its block­buster heart drug as at least 18 com­peti­tors line up for a slice of the grow­ing pie.

En­tresto — a com­bo of sacu­bi­tril and val­sar­tan — has been ap­proved by the FDA since 2015 to re­duce the risk of car­dio­vas­cu­lar death and hos­pi­tal­iza­tion for heart fail­ure in pa­tients with chron­ic heart fail­ure and re­duced ejec­tion frac­tion. In 2021, the FDA ap­proved a sup­ple­men­tal ap­pli­ca­tion for the drug, based on a large tri­al show­ing that the drug’s “ben­e­fits are most clear­ly ev­i­dent in pa­tients with left ven­tric­u­lar ejec­tion frac­tion (LVEF) be­low nor­mal.”

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.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER