Takeda receives approval for cardiovascular outcomes trial

Takeda has announced that the Food and Drug Administration has approved a study proposal for its planned cardiovascular (CV) outcomes trial titled EXAMINE (EXamination of CArdiovascular OutcoMes: AlogliptIN vs Standard of CarE in Patients with type 2 diabetes mellitus and acute coronary syndrome).

The treatment involved in the study is alogliptin, a selective dipeptidyl peptidase IV inhibitor, which is currently under investigation for the treatment of type 2 diabetes in conjunction with a balanced diet and regular exercise.

Nancy Joseph-Ridge, general manager of the firm’s pharmaceutical development division, commented: “While this trial is dependent on the occurrence of CV events, at this point we anticipate that we will be able to submit interim results to the FDA approximately two years after the study begins.”

In June, Takeda revealed that it had submitted a new drug application for alogliptin as a monotherapy. The drug was discovered by Takeda’s wholly-owned subsidiary Takeda San Diego.