US Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 12 to 1 that the data presented support the use of Entresto® (sacubitril/valsartan) in treatment of patients with heart failure with preserved ejection fraction (HFpEF). This was based on data supporting the benefit of Entresto in reducing worsening heart failure (total heart failure [HF] hospitalizations and urgent HF visits) in patients studied in PARAGON-HF. If approved by the FDA, Entresto could become the first therapy indicated for use in treatment of patients with HFpEF, as well as the first medication approved for both major types of chronic heart failure, HFpEF and heart failure with reduced ejection fraction (HFrEF), both based on trials that included active comparators (valsartan and enalapril, respectively).
With no approved therapies for HFpEF to address the prevention of HF hospitalizations and urgent visits, a significant unmet medical need exists for a treatment to reduce the burden associated with this debilitating condition. The FDA is expected to make a decision on the supplemental New Drug Application (sNDA) in the first quarter of 2021.
“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. “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.”
The Committee’s positive decision is based on the totality of evidence from efficacy and safety analyses, including findings presented from a pre-specified subgroup analysis of PARAGON-HF, the largest and only Phase III active-controlled study to date in patients with HFpEF and additional evidence from PARAMOUNT (a Phase II trial in HFpEF), as well as PARADIGM-HF (a Phase III trial in HFrEF). Data from PARAGON-HF demonstrated a favorable safety profile for Entresto in patients with HFpEF, which is in line with the vast clinical and post-marketing experience in HFrEF, and showed clinical benefit of Entresto in HFpEF patients.
“Our commitment to reimagine medicine through our extensive clinical trials program on heart failure has been unwavering, and we are encouraged by the Committee’s response today,” said David Soergel, MD, Global Head of Cardiovascular, Renal and Metabolic Drug Development, Novartis. “We appreciate the valuable insights shared by the patient and advocacy community about this devastating disease, and we look forward to FDA’s decision on the potential approval of this new indication.”
HFpEF affects more than 3 million Americans, and is increasing in prevalence as the population ages. It is a complex disease for which it is difficult to develop treatments due to its heterogeneous pathophysiology and the varied impact of symptoms among patients, despite decades of research. HFpEF can change the structure of the heart and occurs when the muscle tissue of the heart thickens and stiffens so that it cannot expand to fill with enough blood to meet the body’s needs. HFpEF is associated with high rates of recurring heart failure hospitalizations, emergency room visits and urgent doctor’s office appointments. Each hospitalization event is associated with worsening long-term prognosis, and approximately one in four patients are re-admitted for heart failure within one year of discharge.
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