Inside INdiana Business

Lilly drug gains another FDA approval

(Provided Photo/Eli Lilly & Co.)

INDIANAPOLIS (Inside INdiana Business) — The U.S. Food and Drug Administration has awarded another approval for a drug 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 heart failure with reduced ejection fraction. 

Heart failure with reduced ejection fraction, or HFrEF, occurs when the heart muscle does not contract effectively, and less blood is pumped out to the body. Lilly says the condition accounts for more than half of heart failure cases.

Lilly says the approval is based on results from a Phase III clinical trial, which showed Jardiance “significantly reduced the relative risk of the primary composite endpoint of time to cardiovascular death or hospitalization for heart failure by 25%.” Additionally, the trial showed Jardiance significantly reduced the risk of first and recurrent hospitalization by 30%.

“[The] approval is significant for the millions of people diagnosed with this form of heart failure, offering additional hope for those who have seen limited new treatment options over the last decade,” said Dr. Jeff Emmick, vice president of product development for Lilly. “This is the second U.S. regulatory decision stemming from the EMPOWER clinical trial program, which is exploring the impact of Jardiance on major clinical cardiovascular outcomes.”

The European Commission gave similar authorization for the treatment in June.

Jardiance was originally approved 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.


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