Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company announced a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, recommending approval of empagliflozin, an investigational sodium glucose co-transporter 2 (SGLT2) inhibitor, as an adjunct to diet and exercise to improve glycemic control, or blood glucose levels, in adults with type 2 diabetes (T2D).
The positive opinion is based on results from one of the largest clinical registration programs in its class, comprised of more than 10 multinational clinical trials and more than 13,000 adults with T2D. Following a CHMP positive opinion, the European Commission generally follows the recommendation and usually issues its final decision on marketing authorisation within two months.
"The CHMP positive opinion brings us a step closer to having a potential new treatment option for adults in Europe with type 2 diabetes," said Prof Klaus Dugi, corporate senior vice president medicine, Boehringer Ingelheim. "If approved, empagliflozin would be the third product approved in Europe as part of the Boehringer Ingelheim and Eli Lilly and Company Diabetes alliance."
Empagliflozin is a member of the SGLT2 inhibitor class of compounds and is 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 by the kidney.
Approximately 24.4 million Americans and an estimated 382 million people worldwide have type 1 or type 2 diabetes. Type 2 diabetes is the most common type, accounting for an estimated 85 to 95 per cent of all diabetes cases. Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin.
In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in diabetes that centres on compounds representing several of the largest diabetes treatment classes. The alliance leverages the strengths of two of the world's leading pharmaceutical companies. By joining forces, the companies demonstrate commitment in the care of patients with diabetes and stand together to focus on patient needs.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, Connecticut, is the largest US subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.
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