Eli Lilly receives positive EU opinion for diabetes drug

Eli Lilly has announced that it has received a positive opinion from the EU’s Committee for Medicinal Products for Human Use (CHMP) for Byetta (exenatide), a new treatment for type II diabetes.

This means the drug is likely to be approved by the European Commission for marketing throughout the EU next year.

The CHMP’s decision is based on data collated from 35 studies involving almost 4,000 type two diabetes patients in 20 countries, designed to show that the drug is safe and just as effective as insulin.

Additionally, most patients using Byetta in clinical studies demonstrated “significant reductions in weight”.

James Malone, Lilly’s global medical director, said the company was “extremely pleased” by the CHMP’s recommendation because it “validates” the benefit to risk profile of new antidiabetic medicines.

Lorenzo Tallarigo, president of international operations at Lilly, said Byetta is an “exciting” new treatment for patients with type two diabetes who are unable to control their blood sugar levels using metformin and sulfonylurea.

He concluded that the drug was an “important milestone” for Lilly in fighting diabetes.

Byetta is described the first in a new class of medicines known as incretin mimetics, which simulate the action of hormones that can stimulate the body into producing insulin, reduce glucagon levels and reducing food intake in the process.