Eli Lilly and Company (LLY) announced FDA has granted Breakthrough Therapy designation for Jardiance as an investigational treatment for adults with heart failure with preserved ejection fraction. The decision is based on results from the EMPEROR-Preserved phase III trial.
Eli Lilly noted that the FDA previously granted Fast Track designation for the development of Jardiance to reduce the risk of cardiovascular death and hospitalization for heart failure.
Jeff Emmick, vice president, Product Development, Lilly, said: "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."
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