FDA Issues Complete Response Letter to NDA for Alogliptin/Pioglitazone

Takeda announced that it received a complete response letter from the FDA regarding its New Drug Applications (NDAs) for alogliptin and fixed-dose combination alogliptin and pioglitazone (Actos; Takeda) for the treatment of type 2 diabetes.

The FDA has requested additional data which Takeda believes it can supply to the Agency from postmarketing data from outside the US, as well as data from its ongoing clinical trial program.

Alogliptin is a selective dipeptidyl peptidase IV (DPP-4) inhibitor under investigation for the treatment of type 2 diabetes as an adjunct to diet and exercise. Alogliptin is designed to slow the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide), which play roles in regulating blood glucose levels. Pioglitazone is a thiazolidinedione (TZD) also indicated for the treatment of type 2 diabetes as an adjunct to diet and exercise.

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