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Eli Lilly: FDA Accepts Supplemental New Drug Application For Jardiance - Quick Facts

Boehringer Ingelheim and Eli Lilly and Company (LLY) announced the FDA has accepted a supplemental New Drug Application (sNDA) for Jardiance (empagliflozin) for adults with heart failure with reduced ejection fraction. The sNDA was based on results from the EMPEROR-Reduced phase III trial.

Jeff Emmick, vice president, Product Development, Lilly, said: "The results are anticipated this year from the EMPEROR-Preserved trial in adults with heart failure with preserved ejection fraction, an area that currently has no approved treatment options."

Initially approved in 2014, Jardiance is a once-daily tablet used along with diet and exercise to lower blood sugar in adults with type 2 diabetes and to reduce the risk of cardiovascular death in adults with type 2 diabetes and known cardiovascular disease.

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