Takeda gets FDA Complete Response letter for fixed-dose alogliptin and Actos for type 2 diabetes

Japan's leading drugmaker Takeda says that its wholly-owned US subsidiary, Takeda Global Research & Development Center, has received a complete response letter from the US Food and Drug Administration regarding the New Drug Application for the fixed-dose combination of alogliptin and Actos (pioglitazone HCl). The FDA informed Takeda on June 26 that further review of the alogliptin monotherapy NDA would be conditional based upon additional data from a cardiovascular 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, 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,' she added.

The complete response letter was specific to the FDC of alogliptin and Actos, and did not include any new questions or concerns about either compound, according to the company.