Lilly, Boehringer Ingelheim Get FDA OK for Jardiance in Wider Range of Heart Failure

 The U.S. Food and Drug Administration on Thursday said it approved the expanded use of Jardiance, the blockbuster diabetes drug from Eli Lilly & Co. and Boehringer Ingelheim, to reduce the risk of cardiovascular death and hospitalization for heart failure in adults.

The agency said the approval provides a treatment option for a wider range of patients with heart failure, which affects more than 650,000 people in the U.S. each year.

Indianapolis drug maker Eli Lilly and Boehringer Ingelheim, a family-owned pharmaceutical company based in Ingelheim, Germany, jointly market Jardiance as part of a 2011 alliance.

The FDA first approved Jardiance in 2014 for the treatment of adults with insufficiently controlled type 2 diabetes and later approved the drug to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease, and to reduce the risk of death and hospitalization in patients with heart failure and low ejection fraction.

Eli Lilly and Boehringer Ingelheim have previously said that FDA approval of the new indication would make Jardiance the first and only therapy clinically proven to significantly improve outcomes in a heart-failure population that includes a majority of people with preserved ejection fraction.

Eli Lilly reported worldwide Jardiance revenue of $1.49 billion last year.

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