PPD, Inc. has announced that Takeda Pharmaceutical Company Limited reported that Takeda Global Research and Development Center, Inc., a wholly owned U.S. subsidiary, has received notification that the FDA will not be able to complete its review of the alogliptin new drug application (NDA) by the Prescription Drug User Fee Act (PDUFA) date of October 27, 2008. Takeda stated that in its most recent discussion with the FDA, the agency indicated that due to internal resource constraints it would not be able to complete the alogliptin review by the PDUFA date. Although Takeda said the FDA did not provide any guidance on when a review might be completed, Takeda indicated that it remains confident in alogliptin’s potential as a new treatment option for people suffering from type 2 diabetes and reiterated that it will work with the FDA as the agency continues this NDA review. As a result of this notification, PPD does not anticipate the FDA will complete its review of the alogliptin NDA by the end of 2008. Thus, PPD does not expect to receive the $25.0 million alogliptin NDA approval milestone in the fourth quarter of 2008. Alogliptin is a dipeptidyl peptidase IV (DPP-4) inhibitor discovered by Takeda’s wholly owned U.S. subsidiary, Takeda San Diego, Inc. In December 2007, Takeda submitted its NDA for alogliptin for the treatment of type 2 diabetes.
