0944 GMT February 18, 2020
The drug, already approved for reduced fraction heart failure, “narrowly missed” its objectives when tested on patients with preserved ejection fraction type of heart disease which affects 13 million globally, roughly half of all heart failure patients, the company said in a statement, Reuters reported.
Twice-a-day Entresto has the potential for more than $3 billion annual sales for the current indication in patients whose heart muscles do not contract effectively, Novartis has said.
With a possible new indication in heart failure patients in whom the heart muscle contracts normally but the ventricles do not relax as they should, the Basel-based drugmaker saw total annual sales rising to as much as $5 billion. The failure in this trial in 4,822 patients puts the increased sales at risk.
“The trial narrowly missed statistical significance for its composite primary endpoint of reducing cardiovascular death and total heart failure hospitalizations,” Novartis said.