The U.S. Food and Drug Administration has issued approval for a drug from pharmaceutical company Novartis designed to treat heart failure, a leading cause of death in adults.
The drug, Entresto, has gained FDA approval because is has been shown to reduce deaths and hospitalizations for heart failure, the agency said in a statement.
The drug underwent assessment under the agency's priority review program that allows for an expedited evaluation of a drug meant to treat a serious disease or condition when that drug may offer a significant advance over available therapies, the FDA statement explained.
In a clinical trial with more than 8,000 adults, Entresto reduced the rate of cardiovascular death and hospitalizations compared to a current standard generic therapy, enalapril, the FDA reported.
The results of the trial were published in a study appearing in the New England Journal of Medicine.
Cardiologists said the improvement was dramatic.
The drug is "one of the few times that we have identified a medication that is better than the standard," said Clyde Yancy, chief of cardiology at Chicago's Northwestern Memorial Hospital, who has no relationship with Novartis. "It's clearly superior to what we have."
In heart failure, the pumping capacity of a person's heart is reduced, often leading to difficulty breathing that can have them end up in an emergency room.
Of the six million people in the U.S. diagnosed with heart failure, at least half could be candidates for Entresto, which "may fundamentally change their lives for the better," Yancy said.
The twice-daily tablet of Entresto received FDA approval for patients with what is known as a reduced ejection fraction.
Diagnosed in around half of U.S. heart failure patients, it's a condition in which the heart muscle doesn't contract fully, with the result that insufficient blood is pumped through the body.
Novartis said it would immediately begin shipments of Entresto in the U.S.
A spokesman said the U.S. price for the two-tablet dose would be $12.50 per day per patient.
Regulators in the European Union, Switzerland and Canada are also reviewing the drug.
Wall Street analysts are predicting a financial windfall for Novartis, suggesting the drug could generate an annual $6 billion in income by 2024.
Side effects seen in the clinical trial of Entresto included low blood pressure, problems with kidney function, and high levels of potassium in the blood.
Novartis is headquartered in Basel, Switzerland, with U.S. facilities in East Hanover, New Jersey.
