Heart Failure Drug Entresto Gets FDA Approval

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A heart failure drug, manufactured by international pharmaceutical company Novartis, has been approved by the US Food and Drug Administration (FDA) on Tuesday.

According to Novartis' website, Entresto, formerly named LCZ696,  has been proven to reduce cardiovascular death and hospitalization. The FDA approval came six weeks earlier than target, which will make Entresto available for US patients sooner.

The pharmaceutical giant explains that Entestro is an angiotensin receptor neprilysin inhibitor (ARNI) medicine, a combination of two drugs: valsartan, an ingredient found in Diovan, and sacubitril, which represses neprilysin enzymes that assist the ailing heart.

According to the New York Times, when Entresto was subjected to clinical trials almost a year ago, there was a 20 percent decrease in the risk of heart failure death and hospitalization. Heart failure experts have hailed Entresto as a potential replacement for current heart failure medication called angiotensin-converting enzyme (ACE) inhibitors.

International Business Times reports that Entresto will be sold at $12.50 per day for two tablets, excluding discounts from insurance and drug companies, as well as government hospitals. For patients with no insurance, the estimated cost for a whole year would be $4,500.

Heart failure is a progressive condition wherein the heart can't keep up with the body's need for enough blood and oxygen. When the heart muscle can't pump enough blood, the organ will begin to enlarge, pump faster and/or develop more muscle mass, according to the American Heart Association. When the heart begins to decline, symptoms such as fatigue and breathing problems will gradually show. In more advanced stages, it can result in heart attacks and high blood pressure.

According to a press release by the FDA, heart failure affects more than 5 million people in the United States.

"Heart failure is a leading cause of death and disability in adults," said Norman Stockbridge, M.D., Ph.D., from FDA's Center for Drug Evaluation and Research. "Treatment can help people with heart failure live longer and enjoy more active lives."

Novartis division head David Epstein said in a statement that Entresto will be coming to the United States in a few days.

"Despite the uncertainty and high financial risk we designed the world's largest heart failure trial to compare Entresto to the previous gold standard. As a result millions of people diagnosed with reduced ejection fraction heart failure now have a much greater opportunity to live longer and stay out of hospital," Epstein said.

"We recognize our responsibility to ensure Entresto reaches US patients and prescribers as soon as possible and will begin shipping in the US in the coming week."