Takeda Receives FDA Complete Response Letter for the InvestigationalFixed-Dose Combination of alogliptin and ACTOS for theTreatment of Type 2 Diabetes

Fri, 09/04/2009 - 4:40am
TakedaPharmaceutical Company Limited has announced that its whollyowned subsidiary, Takeda Global Research & Development Center, Inc. (U.S.),received on September 2, a complete response letter from the FDA regarding the New Drug Application (NDA)for the fixed-dose combination (FDC) of alogliptin and ACTOS (pioglitazoneHCl). The FDA informed Takeda on June 26, 2009 that further review of thealogliptin monotherapy NDA would be conditional based upon additional datafrom a cardiovascular (CV) safety study that satisfies the statisticalrequirements of the December 2008 FDA Guidance titled, "Guidance for Industry:Diabetes Mellitus - Evaluating Cardiovascular Risk in New AntidiabeticTherapies to Treat Type 2 Diabetes." "This complete response letter from the FDA is consistent with the June 26complete response letter for alogliptin, a key component of the alogliptin andACTOS fixed-dose combination product," said Nancy Joseph-Ridge, M.D., generalmanager, Pharmaceutical Development Division. "The FDA recently agreed to thestudy design for a cardiovascular outcomes trial for alogliptin, titledEXAMINE, and patient enrollment is planned to begin this month. We anticipatethat the EXAMINE trial will provide the FDA with the information needed tocontinue the NDA reviews of both the alogliptin monotherapy and the alogliptinand ACTOS fixed-dose combination." The complete response letter was specific to the FDC of alogliptin andACTOS, and did not include any new questions or concerns about alogliptin orACTOS.



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