PPD Confirms Takeda Receives FDA Complete Response For Alogliptin

Main Category: Diabetes
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 01 Jul 2009 - 3:00 PDT

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PPD, Inc. (NASDAQ: PPDI) today announced that Takeda Pharmaceutical Company Limited issued a news release reporting that Takeda Global Research & Development Center, Inc., its wholly-owned U.S. subsidiary, has received a complete response letter from the U.S. Food and Drug Administration (FDA) regarding its new drug application (NDA) for alogliptin.

PPD is partnering with Takeda 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.

In recent months, the FDA and Takeda have been in discussions about conducting an additional cardiovascular study for alogliptin.

PPD announced on March 6, 2009, 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.

Source
PPD