WILMINGTON, N.C. PPD Inc. announced that Takeda’s wholly owned U.S. subsidiary has received a complete response letter from the Food and Drug Administration regarding its new drug application for alogliptin.
Takeda Global Research & Development Center partnered with PPD to develop alogliptin, a selective dipeptidyl peptidase IV (DPP-4) inhibitor under investigation for the treatment of Type 2 diabetes as an adjunct to diet and exercise.
PPD announced on March 6 that the FDA had informed Takeda that, although the alogliptin NDA was filed prior to the release of the December 2008 FDA guidance titled “Guidance for Industry: Diabetes Mellitus — Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes,” the FDA did not believe that the amount of existing alogliptin clinical data was sufficient to meet certain statistical requirements outlined in that guidance. The FDA has asked Takeda to conduct an additional cardiovascular safety trial that satisfies the December 2008 FDA guidance.
In recent months, the FDA and Takeda have been in discussions about conducting an additional cardiovascular study for alogliptin.
PPD is a leading global contract research organization providing discovery, development and post-approval services, as well as compound partnering programs.