EC Approves Lilly's Jardiance For Type 2 Diabetes In EU

Eli Lilly and collaboration partner Boehringer Ingelheim announced the European Commission’s approval for Jardiance (empagliflozin) tablets for Type 2 diabetes in Europe.

The EC approved Jardiance 10 mg and 25 mg once daily tablets to help T@D patient’s improve their glycemic control when diet and exercise alone are insufficient. Jardiance belongs to the sodium glucose co-transporter-2 (SGLT2) inhibitor class of compounds, which remove excess sugar through the urine. SGLT2 blocks glucose re-absorption in the kidney, in turn removing excess glucose through urine. Jardiance may be used as a stand-alone therapy when metformin cannot be tolerated by a patient. The drug can also be used in combination with other glucose-lowering medicines including insulin, when glucose control is insufficient to manage the disease.

Type 2 diabetes is the most common type of diabetes, which affects around 382 million people in the world and 24.4 million in the U.S. alone. “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. 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,” said Professor Klaus Dugi, CMO of Boehringer Ingelheim.

The EC marketing authorization for Jardiance in T2D was based on positive data from a clinical program encompassing over 10 multinational clinical trials and involving more than 13,000 patients with T2D. Jardiance, when used as a monotherapy or in combination with background treatments, was shown to reduce average blood glucose as well as body weight and blood pressure.

“The approval of empagliflozin marks the third diabetes product from the Boehringer Ingelheim and Lilly Diabetes alliance to be approved in Europe,” said Lilly Diabetes president Enrique Conterno. The two companies first entered into collaboration centered on diabetes treatment compounds in January 2011.