FDA panel backs Novartis’ Entresto for different form of heart disease
pharmafile | December 16, 2020 | News story | Research and Development | FDA, Novartis, heart failure
Novartis’ heart failure drug Entresto has received recommendation from the FDA’s Cardiovascular and Renal Drugs Advisory Committee for use in patients with heart failure with preserved ejection fraction (HFpEF).
The panel voted 12 to 1 that the data presented support that the medicine, currently used to treat people with heart failure with reduced ejection fraction (HFrEF), should be used in treatment of patients with HFpEF.
The Committee’s positive decision is based on the available evidence from efficacy and safety analyses, including findings from a pre-specified subgroup analysis of PARAGON-HF, the largest and only Phase III active-controlled study in patients with HFpEF to date. Data from the study indicated a favourable safety profile for Entresto in HFpEF patients, and showed clinical benefit.
Recommendation of the drug for this new use will aid the Switzerland-based company in their goal to boost sales of Entresto beyond $5 billion a year. The medicine is already approved in 115 countries worldwide for the treatment of HFrEF.
HFpEF affects over three million Americans, and is a complex disease that is difficult to treat – despite decades of research – due to its heterogeneous pathophysiology and the varied impact of symptoms among patients. The condition is associated with high rates of recurring heart failure hospitalisations, emergency room visits and urgent doctor’s appointments, and approximately one in four hospitalised patients are re-admitted for heart failure within one year of discharge.
There is a significant unmet need for treatment of HFpEF – there are currently no approved therapies addressing the prevention of hospitalisations and emergency visits due to the condition. The FDA is expected to make a decision on the supplemental New Drug Application (sNDA) in the first quarter of next year.
Dr David Soergel, Global Head of Cardiovascular, Renal and Metabolic Drug Development at Novartis, said: “Our commitment to reimagine medicine through our extensive clinical trials programme on heart failure has been unwavering, and we are encouraged by the Committee’s response today.
“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.”
Darcy Jimenez
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