FDA grants breakthrough therapy designation to empagliflozin for HFpEF
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The FDA granted breakthrough therapy designation for empagliflozin as an investigational treatment for adults with HF with preserved ejection fraction, Boehringer Ingelheim and Eli Lilly reported.
The decision is based on results from the landmark EMPEROR-Preserved phase III trial, in which empagliflozin (Jardiance, Boehringer Ingelheim/Eli Lilly) demonstrated a 21% relative risk reduction for the composite primary endpoint of CV death or HF hospitalization in adults with HFpEF compared with placebo. The benefit was independent of ejection fraction or diabetes status. Results from EMPEROR-Preserved were presented at the European Society of Cardiology Congress and published in The New England Journal of Medicine.
As Healio previously reported, empagliflozin improved clinical outcomes in patients with HF and reduced ejection fraction with or without diabetes in the EMPEROR-Reduced trial.
There are currently no approved treatments specifically for people with HFpEF.
"This Breakthrough Therapy designation underscores the potential of Jardiance to help fill a critical need for a clinically proven treatment for people with this highly prevalent, difficult-to-treat condition," Mohamed Eid, MD, MPH, MHA, vice president, clinical development and medical affairs, cardio-metabolism and respiratory medicine, Boehringer Ingelheim, said in the release. "Following the recent FDA approval of Jardiance for heart failure with reduced ejection fraction, this is another important milestone supporting the potential of Jardiance as the first therapy clinically proven to improve outcomes across the full heart failure spectrum."
Breakthrough Therapy designation is designed to expedite the development and review of therapies that are intended to treat a serious condition where preliminary clinical evidence indicates potentially substantial improvement over available therapies on a clinically significant endpoint.
"Given the scarcity of treatment options for this debilitating condition, the benefits demonstrated in the EMPEROR-Preserved trial constituted a major clinical breakthrough," Jeff Emmick, MD, PhD, vice president of product development at Eli Lilly, said in the release. "Together with our Boehringer Ingelheim partners, we look forward to working closely with the FDA through this accelerated process to potentially bring Jardiance to adults with heart failure with preserved ejection fraction as soon as possible."
Breakthrough therapies receive priority FDA review; the designation allows early interaction with FDA personnel to expedite the review and approval process.
The FDA previously granted fast track designation for the development of empagliflozin to reduce the risk for CV death and HF hospitalization. This designation is for the EMPEROR program, which consists of the EMPEROR-Reduced and EMPEROR-Preserved trials. The EMPEROR-Reduced results formed the basis of the recent FDA approval for HF with reduced ejection fraction. Empagliflozin is not yet indicated for the treatment of HFpEF.
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