Amylin Pharmaceuticals and Eli Lilly and Company Statement on FDA's BYETTA(R) (Exenatide) Inject... ( SAN DIEGO and INDIANAPOLIS Nov. 2 200...)

Amylin Pharmaceuticals and Eli Lilly and Company Statement on FDA's BYETTA(R) (Exenatide) Injection Update

Date:11/2/2009

SAN DIEGO and INDIANAPOLIS, Nov. 2, 2009 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc., (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) today issued the following statement in response to the U.S. Food and Drug Administration (FDA) update on BYETTA® (exenatide) injection.

"The FDA update issued today aligns with the BYETTA label approved last week. The current label reflects our understanding of post-marketing reports of renal events and provides physicians with updated guidance about appropriate use in patients with renal conditions. There is no evidence from preclinical and clinical studies that BYETTA has any direct toxic effect on the kidney," said Orville G. Kolterman, M.D., senior vice president of research and development, Amylin Pharmaceuticals. "Post-marketing reports of serious changes in renal function have been rare and usually complicated by other factors that could have contributed to the kidney problems. It is also important to note that diabetes is the leading cause of kidney failure. Information about use of BYETTA in patients with impaired renal function was included in the initial product label in 2005 and was updated in 2007. We remain committed to working closely with the FDA to ensure that physicians and patients are provided with accurate information about any potential risks associated with the use of our products."

On October 30, the FDA approved an expanded indication for BYETTA as a stand-alone medication (monotherapy) along with diet and exercise to improve glycemic control in adults with type 2 diabetes. In addition to the monotherapy indication, the FDA approved changes to the BYETTA Prescribing Information to incorporate updated safety information. The new label expands u
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SOURCE Amylin Pharmaceuticals, Inc.
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Amylin Pharmaceuticals and Eli Lilly and Company Statement on FDA's BYETTA(R) (Exenatide) Inject...( SAN DIEGO and INDIANAPOLIS Nov. 2 200...),Health