FDA approves Boehringer/Eli Lilly Alliance type 2 diabetes drug
- Jardiance tablets were co-developed by the Boehringer Ingelheim (BI)/Eli Lilly Alliance for treatment of hyperglycemia in type 2 diabetes patients.
- Jardiance is a sodium glucose co-transporter-2 (SGLT2) inhibitor.
- The clinical trial program that led to the treatment's approval included over 13,000 patients.
Jardiance, a drug developed as part of the BI/Eli Lilly Alliance that was initiated in January 2011, is available in 10- and 25-mg tablets. In June 2014, researchers presented extensive data on Jardiance at the American Diabetes Association meeting in San Francisco. The data focused on 76-week safety and efficacy results that evaluated Jardiance as monotherapy, as add-on therapy to metformin or pioglitazone or as add-on therapy to metformin combined with a sulfonylurea.
"Many adults with type 2 diabetes still have difficulty controlling their blood sugar levels even with treatment," said Boehringer vice president Dr. Christophe Arbet-Engels. "There is a critical need for new treatment options to help these patients.”
The final FDA approval allows Jardiance to be used as monotherapy or as part of a combination therapy; however, the FDA is requiring four additional post-marketing studies for the drug, including a study that focuses on cardiovascular outcomes, a pediatric pharmacokinetic/pharmacodynamic study, a pediatric safety and efficacy study and a nonclinical juvenile toxicity study.