The European Commission granted marketing authorization for Jardiance (empagliflozin) tablets, a sodium glucose co-transporter 2 (SGLT2) inhibitor, for the treatment of type 2 diabetes mellitus (T2D) to improve glycemic control in adults in Europe, Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company announced.
The European Commission approved JARDIANCE 10 and 25 mg once daily tablets for use when diet and exercise alone do not provide adequate glycemic control. JARDIANCE may be used alone when metformin is not considered appropriate due to intolerance, or alongside other glucose-lowering medicines including insulin, when glucose control is inadequate.
JARDIANCE is a member of the sodium glucose co-transporter-2 (SGLT2) inhibitor class of compounds. The emerging SGLT2 inhibitor class removes excess glucose through the urine by blocking glucose re-absorption in the kidney.
"In Europe, the number of people with type 2 diabetes is growing and management of the condition increasingly requires a holistic approach for individuals and their needs," said Professor Klaus Dugi, chief medical officer, Boehringer Ingelheim. "We aim to bring the very latest therapy options to people living with type 2 diabetes and are delighted empagliflozin will become available in Europe." The marketing authorization is based on results from a clinical program comprised of more than 10 multinational clinical trials and more than 13,000 adults with T2D. Phase III studies showed JARDIANCE 10 and 25 mg significantly reduced hemoglobin A1c (A1c, or average blood glucose) as well as body weight and blood pressure as a stand-alone treatment or in combination with a range of background treatments, including metformin, sulfonylureas, insulin and pioglitazone. The most frequently reported adverse reaction was hypoglycemia when used with sulfonylurea or insulin. Common side effects experienced with JARDIANCE were genital infection, urinary tract infection, pruritus and increased urination. Genital infection and urinary tract infection were more common in women than men. JARDIANCE is not indicated for weight loss or as antihypertensive therapy. Weight loss and blood pressure change were secondary or exploratory endpoints in clinical trials.
"The approval of empagliflozin marks the third diabetes product from the Boehringer Ingelheim and Lilly Diabetes alliance to be approved in Europe," said Enrique Conterno, president of Lilly Diabetes. "We are proud to continue with our commitment in supporting the varied treatment needs of people living with type 2 diabetes."