FDA approves expanded indication for sacubitril/valsartan

The FDA has approved an expanded indication for sacubitril/valsartan that includes patients with heart failure with preserved ejection fraction (HFpEF).

Manufactured by Novartis under the name Entresto, sacubitril/valsartan had primarily been associated with treating patients with heart failure with reduced ejection fraction (HFrEF). This expanded indication, according to Novartis, makes Entresto the first medication approved for patients diagnosed with either HFpEF or HFrEF.

In its statement, Novartis noted that the PARAGON-HF trial played a key role in the FDA’s decision. Scott Solomon, MD, a cardiovascular medicine specialist at Brigham and Women’s Hospital in Boston and the PARAGON-HF executive committee co-chair, called the expanded indication “a significant advancement.”

“We can now offer a treatment to a wider range of patients who have an left ventricular ejection fraction below normal,” Solomon said.

“We are proud of our goal to reimagine medicine,” Marie-France Tschudin, president of Novartis Pharmaceuticals, said in the same statement. “This commitment has enabled us to bring Entresto to millions more heart failure patients in the U.S., many of whom did not have an approved treatment option until now.”