Takeda Receives Complete Response Letter From FDA For Alogliptin, ACTOS

Takeda has reported that its wholly-owned subsidiary, Takeda Global Research & Development Center has received a complete response letter from FDA regarding the New Drug Application (NDA) for the fixed-dose combination (FDC) of alogliptin and ACTOS (pioglitazone HCl).

Reportedly, FDA has 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.

Moreover, FDA also said that the data should satisfy 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.

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.

Nancy Joseph-Ridge, general manager of pharmaceutical development division of Takeda, said: 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.

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.