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Amylin's Byetta may have cancer risk

Amylin Pharmaceuticals and Eli Lilly's long-acting Byetta may be tied to an increased cancer risk, a US agency drug reviewer said

Amylin Pharmaceuticals and Eli Lilly's long-acting Byetta (exenatide) may be tied to an increased cancer risk, a US agency drug reviewer said, raising concerns that the diabetes drug may need strict warnings.

The memo, dated January 25, was posted on the Food and Drug Administration's (FDA) website on April 9. It said that Byetta could give a "false sense of security" to physicians and patients about the drug's links to cancer.

Curtis Rosebraugh, head of the FDA's Office of Drug Evaluation II, noted that data from rodent studies on intravenous dosing of Byetta and Bydureon (the weekly version of the drug) "seem to give a similar signal" as seen with Novo Nordisk's Victoza (liraglutide).

Rosebraugh said: "Our internal data indicates that the preclinical findings are not unique to liraglutide but will probably extend to all" similar long-acting GLP-1 analogues, a class of medicines amongst extended-release diabetes drugs which includes Victoza and Byetta. In December, the FDA asked Eli Lilly and Amylin to conduct more safety studies on Byetta. No new studies were ordered for Bydureon.

Victoza was approved in January after 10 months of delay because of safety concerns. During the review, the FDA said thyroid tumours may be common with all extended-release diabetes drugs. The new memo is a the first indication that Byetta will carry the same boxed warning – the agency's strictest warning.

Analysts have said that the boxed warning may dissuade some GPs from prescribing the drug. This may make it harder for GLP-1 analogues to achieve the growth assumed by some investors.

12th April 2010

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