CHMP positive about exenatide in diabetes

USA-based firms Eli Lilly & Co and Amylin Pharmaceuticals say that the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use has issued a positive opinion regarding the use of their co-developed drug exenatide as a treatment for type 2 diabetes. The compound is an incretin mimetic, capable of lowering blood glucose levels in a similar way to naturally-occurring human hormones.

The companies said that their submission to the EMEA contained data from 35 studies, which enrolled a total of 4,000 patients at sites worldwide. Three of the studies, which directly compared exenatide with insulin in the treatment of diabetes, demonstrated that the agent brought about a similar level of blood sugar control. Analysis of the trial data also revealed that most patients treated with the drug experienced significant reductions in body weight.

Amylin and Lilly explained that they are seeking marketing authorization for the agent as an adjunctive therapy, designed to improve control of blood sugar levels in diabetic patients. The firms added that, if the drug is approved, in a decision expected later this year, it will be sold in Europe under the trade name Byetta.