FDA approves Jardiance for T2D - Boehringer/Eli Lilly

The FDA has approved Jardiance (empagliflozin) tablets, from Boehringer and Eli Lilly, as an addition to diet and exercise to improve glycemic control in adults with Type 2 Diabetes. The FDA requires four postmarketing studies for Jardiance: - Completion of an ongoing cardiovascular outcomes trial. - A pediatric pharmacokinetic/pharmacodynamic study. - A pediatric safety and efficacy study. As part of the safety and efficacy study, the effect on bone health and development will be evaluated. - A nonclinical (animal) juvenile toxicity study with a particular focus on renal development, bone development, and growth.

Jardiance was approved in the EU in May 2014, based on a Phase III programme that enrolled over 13,000 patients. Results showed empagliflozin provided a significant reduction in blood sugar from baseline values. Both empagliflozin groups also demonstrated clinically relevant reductions from baseline values in body weight and blood pressure.