The agency is expected to rule on the Novartis treatment in 2021.
A US Food and Drug Administration (FDA) advisory committee has recommended the approval of sacubitril/valsartan (Entresto) to treat patients with heart failure with preserved ejection fraction (HFpEF).
The FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 12-1 to recommend the ultimate approval for the treatment developed by Novartis based on data showing the drug reduces worsening heart failure.
If the treatment garners FDA approval it would become the first therapeutic indicated for use in treatment of patients with HFpEF. It would also potentially become the first medication approved for both major types of chronic heart failure—HFpEF and heart failure with reduced ejection fraction (HFrEF).
In the PARAGON-HF study, the investigators found the drug produced a favorable safety profile in patients with HFpEF, which is in line with the vast clinical and post-marketing experience in HFrEF.
“Managing HFpEF has historically been a clinical and scientific challenge due to the heterogeneity of the condition,” said Scott Solomon, MD, Professor of Medicine at Harvard Medical School and Brigham and Women's Hospital, and PARAGON-HF Executive Committee Co-Chair, in a statement. “Today’s vote represents much needed progress in this area of unmet need and is a positive step toward bringing a potential therapy to millions of patients suffering from this type of heart failure.”
HFpEF is a complex disease that impacts more than 3 million in the US. It has been difficult in the past to develop treatments because of its heterogeneous pathophysiology and the varied impact of symptoms among patients.
The FDA is expected to decide on the approval during the first quarter of 2021.