(Reuters) -The U.S. health regulator said on Thursday it had approved Eli Lilly and partner Boehringer Ingelheim’s drug, Jardiance, for expanded use in reducing the risk of death and hospitalization for all patients with heart failure.
Originally approved by the Food and Drug Administration in 2014 for type 2 diabetes patients, the drug’s use was expanded last year in some adults living with heart failure with reduced ejection fraction, which happens when the muscle of the left ventricle is not pumping as well as normal.
“While Jardiance may not be effective in all patients with heart failure, this approval is a significant step forward for patients and our understanding of heart failure,” said Norman Stockbridge, director of the FDA’s Division of Cardiology and Nephrology.
The expansion on Thursday now increases its market size to cover a very large patient population of about 6.2 million people, as per Centers for Disease Control and Prevention data.
Jardiance also faces competition from AstraZeneca Plc’s drug Farxiga, which has approval for patients with symptomatic heart failure.
Eli Lilly recorded nearly $1.5 billion in revenue for Jardiance in 2021, while Farxiga garnered twice that amount for AstraZeneca.
(Reporting by Leroy Leo in Bengaluru; Editing by Maju Samuel)