Byetta Awarded First-Line Diabetes Status in US

1 November 2009 (Last Updated November 1st, 2009 18:30)

The US Food and Drug Administration (FDA) has granted approval to Amylin and Eli Lilly to market Byetta as a stand-alone medication for adults with type 2 diabetes. Byetta (exenatide) injection had previously only been approved in combination with other common diabetes medications to impr

The US Food and Drug Administration (FDA) has granted approval to Amylin and Eli Lilly to market Byetta as a stand-alone medication for adults with type 2 diabetes.

Byetta (exenatide) injection had previously only been approved in combination with other common diabetes medications to improve glycaemic control. The new indication will allow the treatment to be used alone along with diet and exercise.

Amylin Pharmaceuticals senior vice-president of research and development Orville Kolterman said that the expanded indication increases the number of patients who may benefit from the medication.

"Type 2 diabetes is a complex disease, so it is essential that healthcare professionals and their patients have a wide array of treatments that can effectively control blood glucose levels," Kolterman said.

Approval was granted on the basis of a clinical study of patients with type 2 diabetes, which showed that patients treated with 5mcg or 10mcg of Byetta reduced their A1C over three months by 0.7 percentage points and 0.9 percentage points respectively and managed to achieve significant weight loss.

In addition to the new indication, the FDA also approved updated safety information, including a pancreatitis-related warning related to the alert issued by the FDA in August 2008.