FDA approves an expanded indication for BYETTA injection

Amylin Pharmaceuticals, Inc., (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for BYETTA® (exenatide) injection. BYETTA is now approved for use as a stand-alone medication (monotherapy) along with diet and exercise to improve glycemic control in adults with type 2 diabetes. Previously, it was approved for use only in patients who were also taking other common diabetes medications and had not achieved adequate glycemic control.

"The expanded indication gives physicians the option to prescribe BYETTA as a first-line treatment, increasing the number of patients who may benefit from the medication and providing an opportunity to treat patients with BYETTA earlier in the disease," said Orville G. Kolterman, M.D., senior vice president of research and development, Amylin Pharmaceuticals. "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."

The approval of BYETTA as a monotherapy treatment was based on a clinical study of patients with type 2 diabetes who were unable to achieve glycemic control through diet and exercise alone. Study findings showed that patients treated with 5 mcg or 10 mcg of BYETTA as monotherapy reduced their A1C, a measure of average blood sugar over three months, by 0.7 percentage points and 0.9 percentage points, respectively, and lost 6.0 pounds and 6.4 pounds, respectively. Results of this study were published in Clinical Therapeutics in August 2008.

Among treatment-emergent adverse events, nausea was reported with the greatest incidence (5 mcg, 3 percent; 10 mcg, 13 percent). Hypoglycemia was reported in 5 percent of patients taking 5 mcg and 4 percent of patients taking 10 mcg, with no severe hypoglycemic events.

In addition to the monotherapy indication, the FDA approved changes to the BYETTA Prescribing Information to incorporate updated safety information, including pancreatitis-related language added to the Warnings and Precautions section. This update addresses the alert issued by the FDA in August 2008. The new label also expands upon existing language regarding use of BYETTA in patients with renal impairment. In addition, the label has been amended to match the format the FDA currently uses for Prescribing Information. This label update is being communicated to physicians via a "Dear Healthcare Professional" letter, which will be available at: https://www.astrazeneca-us.com/medicines/astrazeneca-medications.html 

"Patient safety is our foremost concern at Amylin and Lilly, and the BYETTA Prescribing Information represents an important way to communicate the information that healthcare professionals and patients need in order to use the medication safely and effectively," Kolterman continued. "Thus, the updated label offers the most current information about the benefit-risk profile of BYETTA as a foundational therapeutic choice for people with type 2 diabetes."

BYETTA has been used by more than one million patients since market introduction in 2005. It has a proven history with more than 10 million prescriptions written and 6.5 years of clinical experience.