The approval decision follows a positive opinion issued by the European Medicines Agency. Lilly and Amylin anticipate launching Byetta in Europe in 2007.
Byetta, also known as 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 common oral diabetes medications. Byetta is the first in a new class of antidiabetic medicines known as incretin mimetics.
The European Commission based its decision on clinical trials, where Byetta was shown to help patients improve long-term blood sugar control by lowering both fasting and postprandial glucose levels. 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 Byetta lost weight, whereas treatment with insulin was associated with weight gain.
“The rapid increase in the prevalence of diabetes and the need for innovative new treatments has never been more critical than it is today,” said Abbas Hussain, president of European operations for Lilly.