Lilly Launches Jardiance For Type 2 Diabetes In U.S.

Eli Lilly & Co. announced the commercial launch of its Type 2 diabetes treatment Jardiance (empagliflozin) in the U.S. Starting today, Jardiance is available by prescription in pharmacies across the country.

Jardiance is a sodium glucose co-transporter-2 (SGLT2) inhibitor available as a once-daily tablet for patients with T2D. The drug stops glucose from being absorbed in the kidney, thus increasing glucose excretion and lowering blood sugar levels.

Earlier this year, the FDA issued a complete response letter to the Lilly and its collaborator Boehringer Ingelheim’s application for empagliflozin due to observed deficiencies in the Boehringer Ingelheim facility where the drug will be manufactured. BI has since put the manufacturing issues to order and the FDA finally granted approval to the drug this August as an adjunct to diet and exercise for T2D patients.

Kathleen Dowd, SVP of marketing at Boehringer Ingelheim said, “Our alliance is proud to make Jardiance available so quickly following its approval by the FDA. We believe Jardiance is an exciting new treatment option with the potential to help many of the millions of adults with type 2 diabetes who have difficulty controlling their blood sugar levels.”

The FDA approval was supported by positive results from a clinical trial program made up of more than 10 multinational clinical trials involving over 13,000 adults with T2D. Results from Phase III studies show that the drug achieved a significant reduction of hemoglobin A1C, a measure of average blood sugar over the previous two to three months. The drug was investigated as a monotherapy or as part of a combination therapy with different background treatments, including insulin.

The company also noted that the drug induced weight loss and lower blood pressure in the clinical trials.