European regulators have granted approval of the drug Byetta (exenatide) for treatment of type 2 diabetes, and Eli Lilly and Amylin Pharmaceuticals say they expect to launch the diabetes drug in Europe in mid-2007.
Byetta has been available in the United States since last year, when U.S. regulators approved its use in a form that requires twice-daily injections. The drug was approved for patients who have not achieved adequate blood sugar control on metformin or sulfonylurea – two commonly prescribed treatments.
Byetta is the first in a relatively new class of diabetes medicines known as incretin mimetics, which mimic the glucose-lowering actions of naturally occurring hormones.
Amylin and Lilly said the European Commission approved the use of exenatide in the same formulation and treatment that was approved in the United States. The approval follows a positive opinion issued by the Committee for Medicinal Products for Human Use at the European Medicines Agency.
"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 Anthony Barnett, a professor at the U.K.'s University of Birmingham and an investigator in the drug's clinical trials.