Novartis looks to boost blockbuster sales of Entresto with expanded approval

Dec. 17, 2020

Novartis’ Entresto has already far surpassed the blockbuster mark as a treatment for heart failure. Now, the company is on the brink of adding $1.7 billion to its current $5 billion-per-year level of sales.

This week, an FDA advisory panel voted 12-1 in support of expanding Entresto’s approved indications to patients with preserved ejection fraction heart failure — a condition that keeps ventricles from relaxing normally. The FDA committee sided in favor of the drug’s possible expanded indication despite disappointing results from a trial last year showing that the drug missed its main goal — but still had some benefit to patients with heart failure.

Although the FDA is not required to approve a new indication for the drug based on committee vote results, the agency typically follows committee recommendations. 

Novartis stated that it hopes the drug will win an official approval for the new indication by early next year.

Read the Reuters report.