FDA rejects Takeda's diabetes drug, requesting more CV safety analysis

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Takeda Global Research & Development Center, a wholly owned U.S. subsidiary of Takeda Pharmaceutical Company Limited, received on June 26 a complete response letter from the FDA, rejecting its new drug application for 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.

In recent months, the FDA and the Deerfield, Ill.-based Takeda have been in discussions about conducting an additional cardiovascular study for alogliptin. In January, the FDA delayed the alogliptin review an additional six months, after postponing its original Prescription Drug User Fee Act date of Oct. 27, 2008.

The FDA did not believe that the amount of existing alogliptin clinical data was sufficient to meet certain statistical requirements outlined in that December 2008 FDA guidance titled, "Guidance for Industry: Diabetes Mellitus -- Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes." The agency has asked Takeda to conduct an additional cardiovascular safety trial that satisfies the December 2008 FDA guidance.