FDA Approves Takeda's Protocol Design Of EXAMINE Trial For Alogliptin

Published: 28-Aug-2009

FDA requests additional CV safety trial

Takeda Pharmaceutical and Takeda Global Research & Development Center have announed that the latter has received notification, that the FDA has agreed to the study design for a cardiovascular (CV) outcomes trial titled EXAMINE for alogliptin.

Alogliptin, a selective dipeptidyl peptidase IV inhibitor under investigation for the treatment of type 2 diabetes as an adjunct to diet and exercise.

Reportedly, the FDA has requested an additional CV safety trial that satisfies the criteria outlined in the December 2008 Guidance for Industry: Diabetes Mellitus -- Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes.

Nancy Joseph-Ridge, general manager of pharmaceutical development division, at Takeda, said: Takeda received FDA agreement to the design of the CV study and we are pleased to move forward with the study and collecting additional safety data so that the FDA can continue the review of the alogliptin NDA.

We are conducting this study to satisfy the CV safety requirements, leading to the enhancement of the product profile of alogliptin. 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 that will meet the FDA Guidance criteria for drug approval.

Tell your friend about this article