Entresto: FDA Gives Approval to Novartis’ Heart Failure Drug

A new heart failure medication from Novartis that has been proven to decrease death and hospitalizations from heart failure has been approved by the United States’ regulatory agency, the FDA, six weeks ahead of the expected date.

In studies, the combination drug, Entresto, reduced rates of heart-related death and hospitalization compared with older drugs. Heart failure, a disease that causes the heart to gradually lose its pumping power, affects more than 25 million people worldwide.

The condition kills up to half of patients within five years, in defiance of numerous generic pills and other treatments available.

The drug was approved by the FDA under its priority review program, which speeds up review for drugs that treat serious diseases or offer a significant improvement over older drugs.

In April, the agency approved another heart failure from Amgen Inc., Corlanor, the first new FDA-approved medication for heart failure to launch in the U.S. in a dozen years.

Entresto fuses Novartis’ off-patent, blood pressure treatment Diovan (valsartan) with Sacubitril, a new neprilysin inhibitor that raises blood of natriuretic peptides levels in the blood. U.S. pricing for the twice-daily tablet will be $12.50 a day per patient, according to a Novartis spokeswoman.

Novartis studied the drug in more than 8,000 patients with reduced heart pumping ability. Those taking the drug had fewer hospitalizations for heart failure and death from heart disease than patients taking an older heart drug, enalaprilfor, an ACE inhibitor.

Angiotensin–Neprilysin Inhibition versus Enalapril in Heart Failure
John J.V. McMurray, M.D., Milton Packer, M.D., Akshay S. Desai, M.D., M.P.H., Jianjian Gong, Ph.D., Martin P. Lefkowitz, M.D., Adel R. Rizkala, Pharm.D., Jean L. Rouleau, M.D., Victor C. Shi, M.D., Scott D. Solomon, M.D., Karl Swedberg, M.D., Ph.D., and Michael R. Zile, M.D. for the PARADIGM-HF Investigators and Committees
N Engl J Med 2014; 371:993-1004September 11, 2014DOI: 10.1056/NEJMoa1409077