Lilly gets FDA review for empagliflozin in chronic kidney disease

The FDA has accepted a supplemental New Drug Application (sNDA) for Jardiance (empagliflozin) tablets as a potential therapy to reduce the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease (CKD).

Some 37 million people in the U.S. have CKD.

Lilly (NYSE:LLY) is developing the drug with Boehringer Ingelheim.

The supplemental New Drug Application includes data from the landmark EMPA-KIDNEY Phase 3 study, which found that empagliflozin led to a significant reduction in the risk of kidney disease progression or cardiovascular death in adults with CKD. In the study, the drug on top of  standard of care reduced the risk of kidney disease progression or cardiovascular death in adults by 28% compared with placebo.

EMPA-KIDNEY is an abbreviation of Empagliflozin in the Management of Patients with Advanced Chronic Kidney Disease.

The randomized, double-blind, placebo-controlled study (NCT03594110) enroll…

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FDA approves Lilly’s Jardiance for heart failure 

Eli 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 …

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