Novartis’ bid to boost Entresto sales beyond $5 billion gets FDA panel lift
Novartis’ bid to pump up sales of its Entresto heart failure medicine beyond $5 billion annually got a boost when a U.S. Food and Drug advisory panel recommended it be used to treat a different form of the disease.
Entresto, with more than $1.7 billion in sales last year, is currently prescribed for patients whose heart muscles do not contract effectively, but the Swiss drugmaker hopes to win regulatory support for use among heart failure patients whose heart muscle contracts normally but the ventricles do not relax as they should.
A trial of the medicine in such patients missed its main goal in trial results released last year, though Novartis was still optimistic that the data indicated they would benefit and pursued approval.
The FDA advisory committee voted 12 to 1 on Tuesday that the data Novartis presented support the use of Entresto in treatment of patients with so-called preserved ejection fraction heart failure. The U.S. regulator mostly follows such recommendations, and Novartis said on Wednesday that it is hoping for approval of Entresto in the new indication in the first quarter of 2021.
“Today’s vote represents much needed progress in this area of unmet need and is a positive step toward bringing a potential therapy to millions of patients suffering from this type of heart failure,” said Scott Solomon, a Harvard professor and doctor who led the trial of Entresto in preserved ejection fraction heart failure, in a statement issued by Novartis.
