Lilly Drug Gains Additional FDA Approval
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The U.S. Food and Drug Administration has awarded another approval for Jardiance, developed by Indianapolis-based Eli Lilly and Co. (NYSE: LLY) and Boehringer Ingelheim in Germany. The company says Jardiance has been approved to treat adults with any type of heart failure.
Last year, Jardiance was approved to reduce the risk of cardiovascular death plus hospitalization for one type of heart failure: heart failure with reduced left ventricular ejection fraction. Lilly says the latest approval expands the indication to adults with heart failure.
“In its phase III trials, [Jardiance] has shown a statistically significant and clinically meaningful benefit in patients with heart failure across the spectrum of ejection fraction,” said Dr. Javed Butler, chairman of the department of medicine at the University of Mississippi. “Today’s approval means these demonstrated benefits can now help to address a significant unmet need for the approximately 3 million adults in the U.S. with preserved ejection fraction, a form of heart failure that has very limited treatment options.”
Heart failure affects more than six million people in the U.S. and is a leading cause of hospitalization.
Lilly says the approval is based on results from the EMPEROR-Preserved phase III trial, which showed a 21% relative risk reduction for the composite primary endpoint of cardiovascular death or hospitalization for heart failure.
Jardiance was first approved to help adults with type 2 diabetes lower their blood sugar, as well as reduce the risk of cardiovascular death for adults with type 2 diabetes who also have cardiovascular disease.