Takeda Global Research and Development Center, a wholly owned U.S. subsidiary of Takeda Pharmaceutical, has been notified that the FDA will not be able to complete its review of the alogliptin new drug application (NDA) by Oct. 27.
Takeda submitted the NDA for alopliptin, a dipeptidyl peptidase-IV (DPP-4) inhibitor, under investigation for the treatment of type 2 diabetes, in December 2007.
The Osaka, Japan-based Takeda said that due to internal resource constraints, the FDA said it would not be able to complete the alogliptin review in time, in accordance with the Prescription Drug User Fee Act .
Although Takeda said that the FDA did not provide any guidance for when a review might be completed, the company remains confident in alogliptin’s potential as a new treatment option for type 2 diabetes patients, and reiterated that it will work with the FDA as the agency continues this NDA review.
As a result of this notification, the company does not anticipate the FDA will complete its review of the alogliptin NDA by the end of this year, and thus does not expect to receive the $25 million alogliptin NDA approval in the2008 fourth quarter, as previously predicted.