EMEA CHMP RECOMMENDS BYETTA FOR DIABETES

Eli Lilly and Amylin Pharmaceuticals announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Evaluation Agency (EMEA) has issued a positive opinion recommending approval of exenatide for the treatment of Type 2 diabetes. If approved, the companies plan to market the drug throughout the European Union under the proposed brand name Byetta. Marketing authorization by the European Commission is expected later this year.

The companies are seeking approval of exenatide as an adjunctive therapy to improve blood sugar control in patients with Type 2 diabetes who have not achieved adequate control on metformin and/or sulfonylurea, two common oral diabetes medications.

The submission package to support the safety and efficacy profile of Byetta consisted of data collected from 35 studies in nearly 4,000 patients with Type 2 diabetes treated with exenatide in more than 20 countries. Three of the studies compared exenatide with insulin and showed that exenatide can control blood sugar as effectively as insulin. Most patients on exenatide also experienced significant reductions in weight.

Exenatide is the first in a new class of medicines known as incretin mimetics and was approved by the FDA in 2005. The drug exhibits many of the same effects as the human incretin hormone glucagon-like peptide-1, which is secreted in response to food intake and has multiple effects on the intestine, liver, pancreas and brain that work to regulate blood sugar.