Lilly/BoehringerEli Lilly and Company (NYSE:LLY) has announced that the FDA has approved Jardiance (empagliflozin) 10 mg to lower the risk of cardiovascular death and hospitalization in adults with heart failure.

Lilly developed the drug, an SGLT2 inhibitor, in collaboration with Boehringer Ingelheim.

Jardiance is contraindicated in adults with type 1 diabetes, given its potential to elevate the risk of ketoacidosis in such patients.

It is also contraindicated in patients who are hypersensitive to empagliflozin or the excipients in Jardiance.

FDA first approved Jardiance as a treatment for type 2 diabetes in 2014.

In 2016, it won an indication for reducing the risk of cardiovascular death in adults with type 2 diabetes.

Lilly also notes that the drug is not recommended for improving glycemic control in adults with type 2 diabetes with an estimated glomerular filtration rate (eGFR) under 30 mL/min/1.73 m2.

The company notes that the treatment is suitable with an eGFR as low as 20 mL/min/1.73 m2.

To win the approval, Lilly and Boehringer Ingelheim submitted data from Phase 3 trials, including the landmark EMPEROR-Preserved trial. That data showed that the drug resulted in a statistically significant improvement in patients with heart failure regardless of ejection fraction.

“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,” said Dr. Javed Butler, chairman, Department of Medicine at the University of Mississippi.

Jardiance generated almost $4 billion in sales in 2020.

LLY shares ticked up about 2% to $243.00.