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Diabetes-Drug Makers Face FDA Hurdle

The FDA convened an advisory panel last summer that recommended drug companies conduct long-term cardiovascular risk trials for all diabetes drug candidates, regardless of whether there was any prior evidence of a heart safety signal during clinical testing.

The new FDA letters essentially follow up on that recommendation, informing drugmakers that they must collect cardiac safety data for any diabetes drug currently in clinical studies.

The letters do not offer specific instructions on how the data are to be collected. If a company can collect the relevant safety data from existing or ongoing clinical trials, any delay caused by the FDA request may be relatively minor.

However, any company that has to start new studies to collect the heart-safety data could face significant delays and added expense.

Amylin and partner Eli Lilly (LLY) are co-developing Byetta LAR, also known as "exenatide once weekly," a long-acting version of their currently marketed diabetes drug Byetta. A spokesperson for Amylin confirmed the receipt of the FDA letter.

"Amylin and Lilly have discussed our submission plans with the FDA in our pre-NDA [new-drug application] meeting and are confident that we have sufficient clinical data to submit an NDA for exenatide once weekly," she said.

Moreover, she added, "Available clinical trial data for both Byetta and exenatide once weekly do not indicate an increased risk for cardiovascular events."

Novo Nordisk's new diabetes drug liraglutide is currently under FDA review, with an FDA-sponsored advisory committee meeting scheduled for April 2-3, 2009. That meeting is expected to offer clarification as to what the FDA is likely to require of companies with new and pending drug applications.

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