Press Release
Amylin Pharmaceuticals and Eli Lilly Provide Context for FDA Alert for BYETTA
Eli LillyPosted on:29 Aug 08SAN DIEGO and INDIANAPOLIS, Aug 26, 2008 /PRNewswire-FirstCall via COMTEX News Network/ Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) in a conference call today provided context and additional information regarding the August 18, 2008 U.S. Food and Drug Administration (FDA) update to a prior alert for BYETTA® (exenatide) injection referencing pancreatitis. The companies were aware of the pancreatitis cases referenced in the alert, as well as others, and previously reported these cases to the FDA. The complete conference call replay will be available through Amylin's and Lilly's corporate websites after the call.
Since 2006, the U.S. prescribing information for BYETTA has included information about pancreatitis. A recent study has also shown that patients with type 2 diabetes were at nearly three times the risk of developing pancreatitis than those without diabetes.(1) While a definite causal relationship between BYETTA and pancreatitis has not been proved, to better understand the suspected relationship, Amylin and Lilly continue to pursue a comprehensive drug safety program that includes extensive internal and external review of individual cases, and clinical and epidemiologic studies.
"At Amylin and Lilly, patient safety is our foremost concern. We are committed to continuing to work 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," said Orville G. Kolterman, Senior Vice President, Research and Development at Amylin. "It is important to understand that pancreatitis, an inflammatory condition of the pancreas, is a rare event. Further, the characteristics and complications of the pancreatitis cases in patients on BYETTA are consistent with pancreatitis in the general population. We believe BYETTA continues to have a positive benefit-risk profile for patients with type 2 diabetes."
Eli Lilly Editor
http://www.amylin.com
Since 2006, the U.S. prescribing information for BYETTA has included information about pancreatitis. A recent study has also shown that patients with type 2 diabetes were at nearly three times the risk of developing pancreatitis than those without diabetes.(1) While a definite causal relationship between BYETTA and pancreatitis has not been proved, to better understand the suspected relationship, Amylin and Lilly continue to pursue a comprehensive drug safety program that includes extensive internal and external review of individual cases, and clinical and epidemiologic studies.
"At Amylin and Lilly, patient safety is our foremost concern. We are committed to continuing to work 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," said Orville G. Kolterman, Senior Vice President, Research and Development at Amylin. "It is important to understand that pancreatitis, an inflammatory condition of the pancreas, is a rare event. Further, the characteristics and complications of the pancreatitis cases in patients on BYETTA are consistent with pancreatitis in the general population. We believe BYETTA continues to have a positive benefit-risk profile for patients with type 2 diabetes."
For more information:
http://www.amylin.com
Eli Lilly Editor
http://www.amylin.com
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