Novartis' Entresto On Track for New FDA Approval Following Successful AdComm

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Novartis’ Entresto is well on its way to receiving approval as a treatment for heart failure patients following overwhelming support from a U.S. Food and Drug Administration (FDA) advisory committee.

On Monday, the FDA Cardiovascular and Renal Drugs Advisory Committee voted 12 to 1 in favor of approving Entresto (sacubitril/valsartan) as a treatment of patients with heart failure with preserved ejection fraction (HFpEF). The advisory committee's approval 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 assessed in the PARAGON-HF trial. Data from that study demonstrated a safety profile that remained consistent with other Entresto data gathered to date. The study data also showed clinical benefit of Entresto in HFpEF patients, Novartis said. However, the trial narrowly missed its primary endpoint when compared to valsartan. Despite that failure of statistical significance, the company opted to move forward following discussions with regulators.

HFpEF affects more than 3 million people in the United States and that number is expected to grow with the aging population. 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 is associated with worsening long-term prognosis, and approximately one in four patients are re-admitted for heart failure within one year of discharge, the company noted.

Entresto is approved worldwide for the treatment of HFrEF and is expected to generate about $3 billion in annual revenue for the Swiss pharma giant. If the FDA green lights Entresto for this new indication in the first quarter of 2021, Novartis said the drug will become the first therapy that has been approved as a treatment for HFpEF, as well as for both major types of chronic heart failure, HFpEF and heart failure with reduced ejection fraction (HFrEF). There are currently no approved treatments for HFpEF that address the prevention of HF hospitalizations, Novartis said.

"Managing HFpEF has historically been a clinical and scientific challenge due to the heterogeneity of the condition," Scott Solomon, a professor of Medicine at Harvard Medical School and Brigham and Women's Hospital, and co-chair of the PARAGON-HF Executive Committee said 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.”

David Soergel, Global Head of Cardiovascular, Renal and Metabolic Drug Development at Novartis, said the company is highly encouraged by the committee’s vote and looks forward to the FDA’s full decision early next year.

“Our commitment to reimagine medicine through our extensive clinical trials program on heart failure has been unwavering,” Soergel said in a statement.

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