Takeda’s Diabetes Combo Drug Gets Complete Response Letter

Takeda Global Research & Development Center, Inc. received a complete response letter from the FDA regarding its NDA for the fixed-dose combination of alogliptin and Actos (pioglitazone HCl). In June, the FDA said that further review of the NDA would be conditional based on additional data from a cardiovascular safety study that satisfies the 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 letter was specific to the FDC of alogliptin and Actos, and did not include any new questions or concerns about either of the drugs.

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