Takeda Gets Complete Response for Alogliptin, Actos Combination

The FDA has asked Takeda Pharmaceutical in a complete response letter to conduct an additional cardiovascular safety study on its proposed fixed-dose combination of alogliptin and Actos to treat Type 2 diabetes. The FDA has approved the design of a heart-risk study for Takeda’s alogliptin monotherapy application, and the study will apply to both applications, Takeda spokeswoman Julia Ellwanger said. Patient enrollment is scheduled to begin this month.
Washington Drug Letter