NEWS

FDA approves ‘breakthrough’ Novartis heart drug

William Westhoven
@WWesthoven

EAST HANOVER – International pharmaceutical giant Novartis announced Tuesday that the U.S. Food and Drug Administration has approved its new drug previously touted as a “breakthrough therapy” for the majority of more than half of the 6 million Americans with heart failure.

“The approval of Entresto marks a new era in the treatment of heart failure made possible by the collective efforts of our Novartis associates, the hundreds of cardiologists and nurses, and thousands of patients who participated in the research,” said Christi Shaw, U.S. country head and president of Novartis Pharmaceuticals Corp.

The company said Entresto (sacubitril/valsartan) tablets can reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure and reduced ejection fraction, which is a measurement of how well the heart is pumping out blood.

It is usually administered in conjunction with other heart failure therapies, in place of an ACE inhibitor or other angiotensin receptor blocker. Reduced ejection fraction means less blood is pumped because the heart cannot contract with enough force.

According to Novartis, the FDA’s approval was based on results from the largest clinical trial ever conducted in heart failure.

In the study, Entresto demonstrated clinically relevant and statistically significant superiority to ACE-inhibitor enalapril, reducing the risk of cardiovascular death or heart failure hospitalization by 20 percent at a median follow-up of 27 months.

Entresto also improved overall survival by 16 percent versus enalapril, according to the study, driven by the lower incidence of cardiovascular death.

The results of the study were significant enough last year that the study was stopped early after an overseeing committee found that Entresto significantly reduced the risk of cardiovascular death and that the primary endpoint had been met.

“The very meaningful survival advantage of Entresto seen in the trial should persuade physicians to consider Entresto for all appropriate patients, in place of traditional ACE inhibitors or angiotensin receptor blockers,” said Dr. Milton Packer, professor and chair for the Department of Clinical Sciences at University of Texas Southwestern Medical Center. “Entresto is expected to change the management of patients with HFrEF for years to come.”

Nearly 6 million people in the United States suffer from heart failure, and about half have the reduced ejection fraction form. Up to 2.2 million of these patients have heart failure classified as NYHA II-IV, based on how much their symptoms limit physical activity.

“Heart failure places a tremendous physical, emotional and financial burden on patients, their caregivers and society,” said Michele Blair, CEO of the Heart Failure Society of America. “There is a great need in the heart failure community for therapies that improve patient outcomes. Today’s approval is a victory for patients, and we welcome the addition of a new treatment option to help manage this very serious condition.”

Staff Writer William Westhoven: 973-428-6627; wwesthoven@gannettNJ.com