The US FDA has approved Byetta (exenatide) injection as adjunctive therapy to improve blood sugar control in patients with type 2 diabetes who have not achieved adequate control on metformin and/or a sulfonylurea, two common oral diabetes medications, Amylin Pharmaceuticals, Inc., and Eli Lilly and Company jointly announced here. Byetta, the trade name for exenatide, is the first in a new class of medicines known as incretin mimetics.

Byetta improves blood sugar control by lowering both postmeal and fasting glucose levels leading to better long-term control as measured by haemoglobin A1C. Byetta does this through several actions, including the stimulation of insulin secretion only when blood sugar is high and by restoring the first- phase insulin response, an activity of the insulin-producing cells in the pancreas that is lost in patients who have type 2 diabetes. Most patients in the long-term Byetta clinical studies also experienced reductions in weight, the release says.

"The availability of a treatment that lowers blood sugar 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 Dr. David Kendall, Medical Director at International Diabetes Centre in Minneapolis, Minnesota, and an investigator for the Byetta clinical studies. "Byetta is a truly unique tool for the management of type 2 diabetes and is an appropriate option to consider when patients cannot control their blood sugar using one or more oral medications," he added.

"Byetta offers an exciting new option for people with type 2 diabetes and marks an important milestone for Amylin and Lilly's successful collaboration," said Sidney Taurel, chairman and CEO, Eli Lilly and Company.

In addition to approving Byetta for use as an adjunct to existing oral medicines, the FDA also stated that Byetta is approvable as a stand-alone therapy (monotherapy) for patients with type 2 diabetes. Any additional data submitted to support a monotherapy indication is expected to receive a six- month review.