Boehringer Ingelheim Receives FDA Approval For Jardiance In Type 2 Diabetes
By Cyndi Root
Boehringer Ingelheim announced in a press release that it had received two Food and Drug Administration (FDA) approvals in the same week. The federal agency approved Striverdi Respimat (olodaterol) for COPD and Jardiance (empagliflozin) for type 2 diabetes. Jardiance tablets improve glycemic control in conjunction with diet and exercise. Boehringer and Eli Lilly are co-developers of Jardiance in the Eli Lilly and Company Diabetes Alliance.
Prof Klaus Dugi, CMO of Boehringer Ingelheim, said, “Achieving two approvals in close proximity is a rare occasion for a pharmaceutical company and we are very much looking forward to bringing these additional therapeutic options to patients.”
Jardiance
Jardiance (empagliflozin) is a sodium glucose co-transporter-2 (SGLT2) inhibitor that works to block glucose reabsorption in the kidneys, thereby increasing glucose excretion and lowering blood glucose levels. The treatment is approved for adults as a once-daily 10 mg or 25 mg tablet. The medication is not for type 1 diabetes patients or those with diabetic ketoacidosis. Clinical trials showed that some patients experienced modest weight loss, though the drug is not approved for weight loss.
Boehringer and Lilly supported their application for Jardiance with 10 clinical trials with over 13,000 people. The multi-national studies showed a significant reduction in hemoglobin A1C, an average glucose measurement for the previous few months. Trials investigated Jardiance as a stand-alone treatment or with other agents, including metformin, sulfonylureas, insulin, and pioglitazone.
FDA Action
The FDA stated in its press release that serious complications can affect the 26 million people with type 2 diabetes in the U.S. Curtis J. Rosebraugh, director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research, said, “It can be used alone or added to existing treatment regimens to control blood sugar levels in the overall management of diabetes.”
Boehringer and Lilly must complete four post-marketing studies to confirm safety and effectiveness. The two companies must complete an ongoing cardiovascular outcomes trial, a pediatric pharmacokinetic/pharmacodynamic study, a pediatric safety and efficacy study, and a non-clinical (animal) juvenile toxicity study with a particular focus on renal development, bone development, and growth.