Exenatide approved by EC for type 2 diabetes

The European Commission has granted marketing authorisation for exenatide (marketed as Byetta) for the treatment of type 2 diabetes. Lilly and Amylin anticipate launching exenatide in Europe in 2007.

The first in a new class of antidiabetic medicines known as incretin mimetics, exenatide is now approved in the European Union as adjunctive therapy to improve blood sugar control in patients with type 2 diabetes who have not achieved adequate glycaemic control on maximally tolerated doses of metformin or a sulfonylurea, two common oral diabetes medications.

Studies that compared exenatide to insulin showed that exenatide can control blood sugar as effectively as several kinds of insulin often used in patients failing to respond to oral agents. On average, patients treated with exenatide lost weight, whereas treatment with insulin was associated with weight gain.

Exenatide has been shown to work through several actions, including the stimulation of insulin secretion only when blood sugar is above normal and by restoring the first-phase insulin response. First-phase insulin response is a normal process of insulin-producing cells in the pancreas that is lost in patients who develop type 2 diabetes.

"The availability of a treatment that lowers blood sugar to a healthy range, lowers weight, and has the potential to help restore the response of the body's insulin-producing cells is an exciting advance for patients with type 2 diabetes," said professor Anthony Barnett of the University of Birmingham and Birmingham Heartlands Hospital in the UK and an investigator for the exenatide clinical studies.

Exenatide is formulated for self-administration as a fixed dose, subcutaneous injection given prior to the morning and evening meals, or the two main meals of the day. The drug does not require dose adjustment due to the effects of exercise, food intake, or blood glucose monitoring results on the intestine, liver, pancreas and brain that work in concert to regulate blood sugar.