From rxpgnews.com

Diabetes
FDA Approves Exenatide Injection
By Amylin Pharmaceuticals, Inc.; Eli Lilly and Company
Apr 30, 2005, 19:23

Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), and Eli Lilly and Company (NYSE: LLY) announce that the U.S. Food and Drug Administration (FDA) has approved BYETTA(TM) (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. BYETTA (pronounced bye-A-tuh), the trade name for exenatide, is the first in a new class of medicines known as incretin mimetics. BYETTA will be available to pharmacies by June 1, 2005.

BYETTA improves blood sugar control by lowering both postmeal and fasting glucose levels leading to better long-term control as measured by hemoglobin 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 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 Center 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."

Successfully managing diabetes is a daily struggle for millions of Americans," said Ginger L. Graham, President and Chief Executive Officer, Amylin Pharmaceuticals, Inc. "Often, current treatments do not provide adequate blood sugar control leaving patients and caregivers frustrated. BYETTA, a first-in-class medicine, is a new therapy for those who are not able to effectively control their blood sugar with their current oral medications."

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 Chief Executive Officer, Eli Lilly and Company. "With BYETTA's demonstrated effects on blood sugar and its safety profile, physicians and patients now have a new approach to fight the growing diabetes epidemic.

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.

BYETTA is formulated for self-administration as a fixed dose, subcutaneous injection given prior to the morning and evening meals. BYETTA will be made available in both a 5-microgram per dose and a 10-microgram per dose prefilled pen-injector device.

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