Novartis' heart failure drug Entresto has been on the ascent after a slower-than-expected debut on the market, and now the drug has an expanded FDA label that could widen its reach to millions of new patients.
The FDA on Tuesday endorsed Entresto—which already carried an OK in patients with chronic heart failure and reduced ejection fraction—in heart failure with preserved ejection fraction (HFpEF) for patients whose left ventricular ejection fraction (LVEF) is below normal.
With the label expansion, Entresto becomes the first and only drug with clearance in both conditions, Novartis said. About 5 million of the 6 million Americans diagnosed with chronic heart failure can be treated with the drug under its new label.
About 2 million patients with LVEF below normal "did not previously have an approved treatment beyond symptom relief and management of comorbidities," a Novartis spokesperson said. Following the nod, the company plans to "build on our strong relationships and partnerships with professional societies and advocacy groups" to raise awareness of the medicine, and it plans to "deploy our field representatives to begin discussing with doctors immediately."
Previously, many patients weren’t eligible for Entresto “because their ejection fraction was above the region we normally considered reduced,” Harvard Medical School and Brigham and Women’s Hospital professor of medicine Scott Soloman said in a statement. Doctors can now “offer a treatment to a wider range of patients,” he added.
The FDA endorsed Entresto in the new use after the drug narrowly missed its primary goal of reducing cardiovascular-related deaths and hospitalizations among HFpEF patients in a phase 3 study called Paragon-HF.
An HFpEF indication could add up to $1 billion to Entresto’s peak sales estimate, Jefferies analyst Peter Welford wrote in a note to clients last year when an independent FDA panel endorsed the drug in the indication. He had predicted peak sales of $5.1 billion, plus up to $1 billion for the HFpEF use if approved.
After its initial approval in 2015, Entresto ran into early trouble on the market as payers pushed back on its price. The drug had started to gain traction by 2017, and, last year, Entresto generated $2.5 billion, a 45% increase. It’s now Novartis’ third-largest revenue generator.