Boehringer Ingelheim Pharmaceuticals Inc. and Eli Lilly and Co. 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 authorization 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 Professor 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.
Date: March 21, 2014
Source: Eli Lilly and Co.