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BYETTA Approved for Expanded Use as First-Line Treatment for Type 2 Diabetes
Date:10/30/2009

ent 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 www.BYETTA.com.

"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.

About Diabetes

Diabetes affects more than 24 million people in the United States and an estimated 246 million adults worldwide.(ii,iii) Approximately 90-95 percent of those affected have type 2 diabetes. Diabetes is the fifth leading cause of death by disease in the United States and costs approximately $174 bi
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SOURCE Amylin Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
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