Diabetes drug requires more research, FDA rule

Tue, 30 Jun 2009
The American Food and Drug Administration has made it clear to pharmaceutical company PPD Inc. that they must conduct further tests on a diabetes drug being co-developed with Takeda Pharmaceuticals.

The news, released yesterday, is a blow for both of the companies. Alogliptin, had it been approved, would have earned PPD a £25 million milestone payment from Takeda.

The FDA is reviewing Alogliptin under fresh diabetes drug standards and safety guidelines. The FDA and the pharmaceutical industry came under heavy criticism when Avandia was found to increase the risk of heart problems amongst people with diabetes .

The FDA require the submission of a further cardiovascular safety study in the case of Alogliptin, which could delay approval by years.
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