Eli Lilly and company and Amylin Pharmaceuticals, Inc. has announced that the European Commission has granted marketing authorization for Byetta (exenatide) for the treatment of type 2 diabetes.

The approval decision follows a positive opinion adopted September 21, 2006, by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. Lilly and Amylin anticipate launching exenatide in Europe in 2007.

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 glycaemia control on maximally tolerated doses of metformin and a sulfonylurea, two common oral diabetes medications.

The European Commission based its decision on the review and evaluation of a comprehensive data package for exenatide that comprised results of 35 studies and included nearly 4,000 patients with type 2 diabetes across more than 20 countries. In the clinical trials, exenatide was shown to help patients improve long-term blood sugar control by lowering both fasting and postprandial glucose levels (peak levels after meals).

Long-term blood sugar control was measured by haemoglobin A1c, which measures a person's average glucose level over a three-month period and is often used by health care providers to assess blood glucose management. In addition, most patients experienced progressive reductions in weight, a secondary endpoint of the studies.

Studies that compared exenatide to insulin showed that exenatide could 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 United Kingdom and an investigator for the exenatide clinical studies. "Exenatide is an appropriate option to consider when patients cannot control their blood sugar using one or more oral medications."

"More than 48 million people in Europe are estimated to have diabetes," said Abbas Hussain, president of European operations for Lilly. "The rapid increase in the prevalence of diabetes and the need for innovative new treatments has never been more critical than it is today. This approval of exenatide is a major step forward in giving health care professionals and patients in all European countries a new treatment option for the management of type 2 diabetes. Diabetes is an area of tremendous unmet medical need, and we are committed to being a leader in developing new therapies for patients."