Takeda Receives FDA’ Complete Response Letter For Alogliptin

Takeda Global Research and Development Center has received a complete response letter from FDA, regarding the new drug application (NDA) for alogliptin. Its a selective dipeptidyl peptidase IV (DPP-4) inhibitor under investigation, for the treatment of type 2 diabetes as an adjunct to diet and exercise.

Earlier on March 6, 2009, FDA informed Takeda that, although the alogliptin NDA was filed prior to the release of the December 2008 FDA Guidance, the agency did not believe that the existing alogliptin clinical data was sufficient to meet certain statistical requirements, outlined in that Guidance. The FDA’ Guideline was titled: Guidance for Industry: Diabetes Mellitus — Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes,

In view of that, FDA has asked Takeda to conduct an additional cardiovascular safety trial that satisfies the December 2008 FDA Guidance.