FDA update on BYETTA injection: Amylin Pharmaceuticals and Eli Lilly respond

Amylin Pharmaceuticals, Inc.Nov 3 2009

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 upon existing language regarding use of BYETTA in patients with renal impairment, which Amylin and Lilly updated in September 2007 to include additional language regarding renal adverse events. It specifies that BYETTA should not be used in patients with severe renal impairment or end-stage renal disease and should be used with caution in patients with renal transplantation. It also specifies that because BYETTA may induce nausea and vomiting with transient hypovolemia (low blood volume), treatment may worsen renal function. This update was communicated to physicians via a "Dear Healthcare Professional" letter, which is available at: https://www.astrazeneca-us.com/medicines/astrazeneca-medications.html

BYETTA has extensive post-marketing experience and a well-documented safety profile. 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.