Contract research organization Pharmaceutical Product Development, Inc., or PPD, (PPDI) on Monday said that Takeda Pharmaceutical Company Ltd. was granted a complete response letter by the U.S. Food and Drug Administration, or FDA, regarding its new drug application, or NDA, for alogliptin, indicated for the treatment of type 2 diabetes.
Wilmington, North Carolina-based PPD is partnering with Takeda to formulate alogliptin, a selective dipeptidyl peptidase IV, or DPP-4 inhibitor under investigation for the treatment of type 2 diabetes as supplement to diet and exercise.
Earlier on March 6, 2009, Pharmaceutical Product Development had announced that the FDA had informed Takeda that it did not believe that the amount of existing alogliptin clinical data was sufficient to meet certain statistical requirements outlined in the "Guidance for Industry: Diabetes Mellitus — Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes."
Subsequently, the FDA had asked Takeda to conduct an additional cardiovascular safety trial that satisfies the December 2008 FDA guidance.
The complete response letter was received by Takeda's wholly-owned U.S. subsidiary Takeda Global Research & Development Center, Inc.
PPDI is currently trading at $22.72, down $0.60 or 2.57%, on the Nasdaq.
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