By Thomas M. Burton And Peter Loftus 

The Food and Drug Administration approved a promising new heart-failure drug from Novartis AG that cardiologists say could potentially improve the lives of millions of patients with the condition.

The drug, called Entresto, was studied in a clinical trial of more than 8,000 adults and--in a rare development--reduced the rate of cardiovascular death and hospitalization compared to a standard generic therapy, enalapril.

Clyde Yancy, chief of cardiology at Chicago's Northwestern Memorial Hospital, said that Entresto is "one of the few times that we have identified a medication that is better than the standard. It's clearly superior to what we have."

Dr. Yancy, a heart-failure specialist, doesn't have any relationship with the drug's maker. He estimated that of the six million people in the U.S. with heart failure, "at least half may be candidates" for the medicine. And he said that the drug "may fundamentally change their lives for the better."

Heart failure is a condition in which the patient's heart has lost some of its pumping capacity, and it can degenerate into a situation where patients have difficulty breathing and end up in the emergency room. Dr. Yancy said the drug is especially useful in "the comfortable patient who can tolerate full doses of therapy."

Since most of the existing treatments for heart failure are lower-cost generics, the test for the new treatment may in part be an economic one. Insurers increasingly are balking at the high cost of drugs such as those for cancer and hepatitis C.

Wall Street predicts Entresto will be a blockbuster, with Leerink Partners estimating that annual global sales could top $6 billion by 2024. That would help Switzerland's Novartis weather impending generic competition for cancer drug Gleevec.

The U.S. price for the twice-daily tablet will be $12.50 a day per patient, according to a Novartis spokeswoman. The company is in early-stage discussions with some U.S. health payers to link the drug's price to clinical outcomes in patients who take it, such as the rate of hospitalizations for heart failure, the spokeswoman said. The company didn't identify the payers, and it said it was too early to share more specifics.

Drug makers and payers have increasingly explored such "pay-for-performance" pricing models--rather than paying a fixed per-pill or per-vial cost--amid complaints about the rising price of medications.

Steve Miller, chief medical officer of the pharmacy-benefits manager Express Scripts Inc., said that "outcomes-based pricing clearly comes with some logistical challenges, but it is worth considering as a strategy to get this drug to the right patients."

Write to Thomas M. Burton at tom.burton@wsj.com and Peter Loftus at peter.loftus@wsj.com

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