FDA Gives Green Signal To ‘Entresto’ The New Heart Drug – Cuts Death Risk by 20%

Excitement grows as the Food and Drug Administration approves a new heart failure drug ‘Entresto’ from Novartis that has been 20 % reduction in the risk of death from cardiovascular causes or hospitalization for worsening heart failure. The results were revealed after a large clinical trial nearly a year ago.

Novartis has already predicted that Entresto can potentially achieve more than $5 billion in annual sales globally, making it one of the world’s best-selling medications. Daily expense of the drug has been estimated to be $12.50, or about $4,500 for a year, with two tablets taken daily.

Mr. Epstein said the price was “really quite reasonable,” given that some drugs for other diseases cost many times that amount and confer less benefit. He said the company could make the case that Entresto could save money over all by keeping people out of the hospital.

“This is one of those once-in-a-decade kind of breakthroughs, to get a drug that extends life so substantially,” David Epstein, the head of Novartis’s pharmaceutical division, said in an interview.

Heart failure affects more than five million people in the United States, and approximately 26 million people worldwide. The condition, sometimes known as congestive heart failure, occurs when your heart muscle is not able to pump blood as effectively as it should. Certain conditions, such as narrowed arteries in your heart (coronary artery disease) or high blood pressure, gradually leave your heart too weak or stiff to fill and pump efficiently (Mayoclinic)

Heart failure can cause shortness of breath, fatigue and retention of fluids and is one of the leading causes of hospitalization, if not the leading cause.

Some heart failure experts are saying that Entresto – titled LCZ696 during its development, may just replace the existing mainstay treatments for chronic heart failure – drugs which fall into the category of angiotensin-converting enzyme (ACE) inhibitors or somewhat similar angiotensin II receptor blockers.

That said, the ACE inhibitors Entresto will be competing with are largely inexpensive generics, so some health plans could conceivably be reluctant to pay for Novartis’s product.

Novartis is considering trying so-called risk-sharing with some health plans, meaning it might charge more if the drug really does keep people out of the hospital and less if it doesn’t. But such talks, while encouraging, are still in the early stages, a Novartis spokesman said.

Timothy Anderson, pharmaceutical analyst at Sanford C. Bernstein & Company, said in a recent note that Entresto was “likely to become a mega-brand over time” but that the initial uptake was “likely to be on the slower side given the entrenched nature of off-patent ACE inhibitors.” He said it was highly unusual that there were no major competitors for Entresto on the way, giving it a “long runway.”

In a clinical trial with more than 8,400 participants, patients were randomly assigned to take either Entresto or enalapril, an ACE inhibitor. Patients in both groups of the study could also take other drugs, such as beta blockers, as their doctors saw fit.

After about 27 months, 21.8% of those taking Entresto had either died from cardiovascular causes or had been hospitalized for worsening heart failure, compared with 26.5 percent for those taking enalapril. That represented a relative risk reduction of 20 percent using a measure known as the hazard ratio.

Novartis said that about 2.2 million Americans would be eligible for the drug, which was approved for patients with so-called Class II to Class IV chronic heart failure with so-called reduced ejection fraction. Novartis is sponsoring another study to see if the drug is effective for those with preserved ejection fraction, which accounts for half of heart failure cases.

The F.D.A. said that the main side effects were low blood pressure, high blood potassium levels and kidney impairment. It said there were also cases of angioedema, an allergic reaction that usually results in swelling of the lips or face but can be life threatening if swelling interferes with breathing. Blacks and those with a previous history of the condition were at increased risk, it said.

Entresto is an amalgamation of two drugs: one of which is valsartan, the active ingredient in the blockbuster drug that Novartis sells as Diovan but which now faces generic competition. The other ingredient, sacubitril, inhibits an enzyme known as neprilysin, a new mechanism of action for a heart failure drug.

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