The European Medicines Agency (EMA) has accepted for review Boehringer Ingelheim and Eli Lilly and Company's marketing authorization application (MAA) for the investigational sodium glucose co-transporter-2 (SGLT2) inhibitor empagliflozin, for the treatment of type 2 diabetes mellitus (T2D) in adults. The acceptance of the MAA marks the beginning of the review process in the European Union for this potential oral diabetes treatment.

"We are pleased the EMA has accepted our marketing authorization application for a potential new treatment option to help patients better manage their type 2 diabetes mellitus," said Prof. Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. "More than 300 million people worldwide live with type 2 diabetes mellitus and varied approaches to treating this condition are needed to help these patients better manage their condition."

A New Drug Application for empagliflozin was recently submitted to the Food and Drug Administration (FDA) in the United States for the treatment of T2D in adults.

Empagliflozin is a member of the SGLT2 inhibitor class of drugs being investigated for the reduction of blood glucose levels in adults with T2D. The emerging SGLT2 inhibitor class removes excess glucose through the urine by blocking glucose re-absorption in the kidney.

T2D is the most common type, accounting for an estimated 90 percent of all diabetes cases. Diabetes is a chronic disease that occurs when the body either does not properly produce, or use, the hormone insulin. Diabetes was estimated to cost the US$ 245 billion in direct medical costs and reduced productivity in 2012.

In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in the field of diabetes that centres on three pipeline compounds representing several of the largest treatment classes. This alliance leverages the companies' strengths as two of the world's leading pharmaceutical companies, combining Boehringer Ingelheim's solid track record of research-driven innovation and Lilly's innovative research, experience, and pioneering history in diabetes. By joining forces, the companies demonstrate commitment in the care of patients with diabetes and stand together to focus on patient needs.

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. The company is committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Lilly has been a global leader in diabetes care and works to meet the diverse needs of people with diabetes through research and collaboration, a broad and growing product portfolio and our continued commitment to providing real solutions — from medicines to support programs and more — to make lives better.