Amylin Pharmaceuticals Inc. (AMLN)

[surf1944]

3:32PM Amylin Pharms and Eli Lilly and Company issue statement on FDA's BYETTA injection update (AMLN) 12.17 +1.13 : Amylin Pharmaceuticals and Eli Lilly (LLY) issued the following statement in response to the 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... 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."