Swiss pharma giant Novartis SA (NVSEF) said late Wednesday that the U.S. Food and Drug Administration (FDA) has approved its new heart drug Entresto, touted as a possible blockbuster.
The approval is a huge relief for the company, which had spent heavily on staging the world’s largest heart failure trial, covering over 8,000 patients. Novartis, like other major pharma companies, needs new blockbusters to deal with its ‘patent cliff’ problem, as its older drugs lose their patent protection and earning power.
Entresto, previously known as LCZ696, is designed to be used in conjunction with other heart failure therapies in place of an ACE inhibitor or other angiotensin receptor blockers. The trial showed significantly better patient outcomes than with the standard ACE inhibitor enalapril, cutting death rates by 20%.
“Millions of people diagnosed with reduced ejection fraction heart failure now have a much greater opportunity to live longer and stay out of hospital,” said David Epstein, head of Novartis’ Pharmaceuticals division. “We recognize our responsibility to ensure Entresto reaches U.S. patients and prescribers as soon as possible and will begin shipping in the U.S. in the coming week.”
About half of the 6 million Americans who suffer from heart failure have the ‘reduced ejection fraction’ form of the problem, where the heart fails to pump enough blood out into the body. The condition is also known as systolic heart failure.
Entresto is currently undergoing review by health authorities around the world, including in Canada, Switzerland and the E.U.. Once approved by health authorities around the world, Entresto could achieve estimated peak sales in excess of $5 billion, the company said.