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This press release is an announcement submitted by Reuters Health, and was not written by Diabetes Health.
BOSTON/NEW YORK, Dec 23 (Reuters) - The shares of Amylin Pharmaceuticals Inc (AMLN.O) fell nearly 10 percent on Wednesday after the U.S. Food and Drug Administration requested that the company conduct additional safety studies on its diabetes drug, Byetta.
A letter posted on the FDA's website requested the additional studies to ensure the benefits of Byetta, known generically as exenatide, outweigh the risk of inflammation of the pancreas and acute renal failure.
"We have determined that postmarketing requirements are needed to assess the risk of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, and the risk of thyroid neoplasms," the agency said in a letter to the company.
Thyroid neoplasms usually refer to cancer of the thyroid.
"This is all new information to us," said Yaron Werber, an analyst at Citigroup.
Werber noted the FDA is requiring Amylin to conduct an epidemiological study on acute pancreatitis in Byetta versus non-Byetta patients; epidemiologic queries on pancreatic cancer and thyroid neoplasm in Byetta versus patients taking certain alternative therapies; a clinical trial to see whether Byetta may increase the risk of gall bladder gallstones and therefore pancreatitis.
Epidemiological studies are designed to assess the prevalence of disease in different groups of people.
Amylin said in a statment on Wednesday afternoon that a study has shown "no increased risk of pancreatitis in patients taking Byetta compared to patients taking other antidiabetic medications."
Amylin also said a pre-clinical program demonstrated "no increased risk of pancreatitis with Byetta" and that it is studying Byetta and gall bladder gallstones.
Amylin's shares fell 9.6 percent to close on Wednesday at $13.97 on Nasdaq. (Reporting by Toni Clarke and Ernest Scheyder; editing by Andre Grenon)
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1 comment - Dec 28, 2009
Diabetes Health is the essential resource for people living with diabetes- both newly diagnosed and experienced as well as the professionals who care for them. We provide balanced expert news and information on living healthfully with diabetes. Each issue includes cutting-edge editorial coverage of new products, research, treatment options, and meaningful lifestyle issues.