Novartis AG's heart failure drug, Entresto, was approved by the U.S. Food and Drug Aministration, six weeks ahead its action date.

Entresto (sacubitril/valsartan) has shown to reduce the mortality rates and hospitalization rates related to heart failure, said the FDA in a statement on Tuesday, reports Reuters.

Like Us on Facebook

As stated by Novartis, Entresto is "indicated to reduce the risk of cardiovascular death and heart failure hospitalization in patients with chronic heart failure (NYHA class II-IV) and reduced ejection fraction. The drug is usually administered in combination with other heart failure drugs, in place of an ACE inhibitor or other ARB."

Heart failure affects about 5.1 million people in the United States. It is a fairly common condition where the heart can no longer pump enough blood to supply the body's needs. This condition naturally worsens over time as the heart's contractility becomes weaker. Primary causes of heart failure include those diseases that damage the heart, such as heart attacks and increased blood pressure.

According to Norman Stockbridge, M.D., Ph.D., the director of the Division of Cardiovascular and Renal Products in the FDA/s Center for Drug Evaluation and Research, "Heart failure is one of the primary causes of death and disability in adults. This treatment can aid people with heart failure live longer and enjoy more active lives." 

Being the first in the new class of drugs known as Angiotensin Receptor Neprilysin Inhibitors or ARNIs, it is made up of valsartan, a well-known angiotensin receptor blocker, and a novel compound, the neprilysin inhibitor, sacubitiril. When neprilysin is inhibited, it will reduce the neurohormonal activation that helps drive heart failure processes such as constriction of the blood vessels, sodium retention and remodeling. This was designed to avoid angioedema, an allergic reaction usually appearing as swelling of the lips or face, which is a side effect of the previously doomed same class drug, omapatrilat, which is a mixture of an ACE inhibitor and neprilysin inhibitor.

Entresto will be available in three dosage strengths: 24/26 mg, 49/51 mg and 97/103 mg (sacubitril/valsartan). It is recommended that patients should start with the middle dose and move to the higher dose after 2-4 weeks. The lesser dose may be preferred, depending on the case of the patient, Forbes has learned.

Entresto was subjected to a clinical trial of more than 8,000 adults and was shown to reduce mortality and hospitalizations related to heart failure in comparison to another drug, enalapril. Pateints in trial were also receiving approved heart failure medications which include diuretics, beta-blockers, and antagonists of mineralocorticoid production.

The most common side effects suffered by the participants in the clinical trial treated with Entresto were hypotension, hyperkalemia, and renal impairment.

Health care providers should inform the patients about the risk of harm to an unborn baby if pregnancy is detected. Its use of during pregnancy should be discontinued as soon as possible.

The FDA protects the public health by ensuring the safeness, effectivity, and security of both human and veterinary drugs, vaccines and other products for human use, and medical devices. The agency also is amenable for the safety and security of the whole nation's food supply, cosmetics, dietary supplements, products that may be harmful by giving off electronic radiation, and for regulating tobacco products.

TagsHeart Drug, Entresto, FDA, Heart failure, death