Takeda Pharmaceutical Company Limited ("Takeda") today announced that its wholly owned subsidiary, Takeda Global Research & Development Center, Inc. (U.S.), received on September 2 (U.S. TIME), a complete response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for the fixed-dose combination (FDC) of alogliptin and ACTOS(R) (pioglitazone HCl). The FDA informed Takeda on June 26, 2009 that further review of the alogliptin monotherapy NDA would be conditional based upon additional data from a cardiovascular (CV) safety study that satisfies the statistical requirements of the December 2008 FDA Guidance titled, "Guidance for Industry: Diabetes Mellitus - Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes."
"This complete response letter from the FDA is consistent with the June 26 complete response letter for alogliptin, a key component of the alogliptin and ACTOS fixed-dose combination product," said Nancy Joseph-Ridge, M.D., general manager, Pharmaceutical Development Division. "The FDA recently agreed to the study design for a cardiovascular outcomes trial for alogliptin, titled EXAMINE, and patient enrollment is planned to begin this month. We anticipate that the EXAMINE trial will provide the FDA with the information needed to continue the NDA reviews of both the alogliptin monotherapy and the alogliptin and ACTOS fixed-dose combination."
The complete response letter was specific to the FDC of alogliptin and ACTOS, and did not include any new questions or concerns about alogliptin or ACTOS.