EU approves Jardiance for Type 2 Diabetes - Boehringer/Eli Lilly

The European Commission has granted Marketing Authorisation for Jardiance (empagliflozin), from Boehringer and Eli Lilly, for the treatment of Type 2 Diabetes to improve glycaemic control in adults. Empagliflozin 10 and 25 mg once daily tablets is approved for use when diet and exercise alone do not provide adequate glycaemic control. It is indicated alone when metformin is not considered appropriate due to intolerance, and alongside other glucose-lowering medicines including insulin when glucose control is inadequate.

The Phase III programme that supported the authorisation 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. When used as monotherapy, most adults did not experience side effects such as weight gain, low blood sugar and gastrointestinal issues. Common side effects experienced with empagliflozin were genital infection, urinary tract infection and increased urination.