FDA requests CV data for alogliptin

Takeda (Tokyo:4502) said FDA does not find existing data on alogliptin ( SYR-322) sufficient to meet requirements set out in a December 2008 guidance on cardiovascular risk evaluation for diabetes treatments. The PDUFA date for an NDA for the selective dipeptidyl peptidase-4 (DPP-4) inhibitor to treat Type II diabetes as an adjunct to diet and exercise remains June 26. It was delayed once last fall because of FDA resource constraints.

Under the guidance, a company to must rule out an 80% increase in CV risk and conduct postmarketing trials, which must subsequently demonstrate an increase in CV risk of no more than 30%. Takeda said FDA is willing to discuss the design of additional CV trials (See BioCentury, Dec. 15, 2008). ...