Blockbuster heart drug Entresto gets expanded indication

FDA’s approval of a broader indication for sacubitril/valsartan (Entresto, Novartis) is expected to generate signficant additional sales of the drug that netted $1.7 billion in sales last year.

FDA approved the expanded indication to reduce the risk of cardiovascular death and hospitalization in a specific type of heart failure. The benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal, Novartis said in a press release.

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Entresto is already approved to treat heart failure with reduced ejection fraction (HFrEF).

“For the first time, there is a treatment with benefit for patients diagnosed with guideline-defined heart failure that includes both those with heart failure with reduced ejection fraction (HFrEF) and many with heart failure with preserved ejection fraction (HFpEF)1-3,” Novartis said.

Many heart failure patients were not previously eligible for treatment before because “their ejection fraction was above the region we normally considered reduced,” said Scott Solomon, MD, professor of medicine at Harvard Medical School and Brigham and Women's Hospital, and PARAGON-HF Executive Committee Co-Chair. “We can now offer a treatment to a wider range of patients who have an LVEF below normal.”

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The label expansion is based on efficacy and safety results from the PARAGON-HF, which Novartis says is the largest and only Phase 3 active-controlled study to date in patients with guideline-defined HFpEF2,5,6.

In the trial, the greatest benefit was shown in patients with LVEF below normal, Novartis said.

Around 6 million Americans are living with chronic heart failure (CHF). Approximately 3 million have HFrEF, and of the remaining 3 million, about 2 million have HFpEF with LVEF below normal, according to Novartis.

The expanded indication is important because CHF patients often face worsening symptoms that result in frequent heart failure hospitalizations and approximately 1 in 4 patients are re-admitted for heart failure. In addition, 10% may die within 30 days of discharge, Novartis said.

Read more: Drug’s indication expanded to reduce heart attack, stroke risk