The well-known and commonly prescribed heart-failure drug, Entresto (sacubitril and valsartan) has helped many patients suffering with heart failure since its initial approval in 2015. Recently the FDA announced approval for an expanded indication for reducing the risk of cardiovascular death and hospitalization for heart failure (HF) in adult patients with chronic heart failure.

According to Novartis, the manufacturer, up to 5 million of the 6 million individuals in the United States with chronic heart failure could be potential candidates for treatment with Entresto. In a press release on February 16, 2021, Novartis announced that the FDA granted the following expanded indication for Entresto (sacubitril/valsartan) to reduce the risk of cardiovascular death and hospitalization for HF in adult patients with chronic HF. The clinical benefits are most clearly apparent in patients with left ventricular ejection fraction (LVEF) below normal. The updated label also states LVEF is a variable measure and clinical judgment should be utilized by prescribers in deciding whom to treat.

The press release also stated that Entresto is the first and only therapy approved in the U.S. to treat patients diagnosed with guideline-defined HF to include both those with HF with reduced ejection fraction (HFrEF) and many with HF with preserved ejection fraction (HFpEF). The manufacturer states that this recent approval could offer a new treatment option for up to 2 million individuals with chronic HF who, until now, have only had drugs to manage symptoms and comorbidities.

Novartis has established the biggest global clinical program in the HF disease area across the pharma industry to date. Known as FortiHFy, it consists of more than 40 clinical studies designed to produce an assortment of additional data on efficacy, quality of life, patient-reported outcomes, and real-world evidence with the use of Entresto, as well as to extend understanding of HF. The FortiHFy program includes trials across the spectrum of HF, such as PARADIGM-HF, PIONEER-HF, TRANSITION, PROVE-HF, PARAGON-HF, and PARAMOUNT.

This recent label expansion is based on efficacy and safety evidence observed in PARAGON-HF, the largest and only phase III active-controlled study to date in patients with guideline-defined HFpEF. The greatest benefit was demonstrated in patients with LVEF below normal.  Scott Solomon, MD, professor of medicine at Harvard Medical School and Brigham and Women’s Hospital, and PARAGON-HF Executive Committee co-chair, stated in the press release, “This approval is a significant advancement, providing a treatment to many patients who were not eligible for treatment before because their ejection fraction was above the region we normally considered reduced. Until now, treatment for these patients was largely empiric. We can now offer a treatment to a wider range of patients who have an LVEF below normal.”

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