Novartis Wins U.S. FDA Approval for Heart-Failure Treatment

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Novartis AG won U.S. approval to sell a first-of-its-kind drug to treat heart failure, a leading cause of death among adults.

The Food and Drug Administration cleared the medicine, called Entresto, which has been shown to reduce deaths and hospitalization due to heart failure, the agency said Tuesday in a statement. The treatment combines the Novartis drug Diovan, which treats high blood pressure, with another drug called sacubitril. It’s the first in its class that reduces the strain on the heart, according to a statement from the Basel, Switzerland-based company.

The drug may become Novartis’s biggest-selling product by 2019, according to analyst estimates compiled by Bloomberg. Novartis said it expects Entresto to reach peak sales of at least $5 billion a year, while Andrew Baum, an analyst at Citigroup Inc. in London, said the drug may garner as much as $11 billion.

“The peak sales potential of Entresto as well as the speed of the ramp up” have been underestimated, Baum wrote in a note.

Novartis rose 2.2 percent to 94.45 Swiss francs as of 9:08 a.m. in Zurich. The stock has gained about 20 percent in the past year, including reinvested dividends, trailing a 25 percent advance in the Bloomberg Europe Pharmaceuticals Index.

’Live Longer’

About 5.1 million Americans suffer from heart failure, which usually worsens over time as the heart grows weaker, according to the FDA. Heart failure is often caused by cardiovascular damage from heart attacks and high blood pressure, the agency said in a statement.

“Treatment can help people with heart failure live longer and enjoy more active lives,” Norman Stockbridge, the FDA’s director of the Division of Cardiovascular and Renal Products, said in the agency’s statement.

Novartis will sell Entresto for $12.50 a day in the U.S., which is “on the higher end of expectations,” said Tim Anderson, an analyst at Sanford C Bernstein & Co. in New York. “Given the strength of the data, payers will essentially have no choice but to cover the drug,” he wrote in a note.

The twice-daily tablet was approved for heart failure patients who have what is called a reduced ejection fraction, meaning the heart muscle isn’t contracting effectively and can’t pump enough blood to the body, according to Novartis. About half of U.S. heart failure patients have reduced ejection fraction, the company said.

Lower Risk

Research published last year in the New England Journal of Medicine found Entresto reduced the risk of death and hospitalization from heart failure by 20 percent compared with the standard therapy, enalapril.

“We’re about to launch what I think is one of the most remarkable drugs in cardiovascular medicine in the last several decades, and certainly one of the most important medicines for our company,” David Epstein, head of Novartis’s pharmaceuticals division, said on a conference call today.

Novartis plans to begin shipping Entresto to the U.S. in the coming week, according to the statement. Regulators in Canada, Switzerland and the European Union are reviewing Entresto for approval.

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