ARTICLE | Clinical News

Cangrelor regulatory update

May 5, 2014 7:00 AM UTC

According to The Medicines Co., FDA recommended that for the PCI indication, the company "perform a series of clinical data analyses" of the Phase III CHAMPION PHOENIX trial, review data management processes and provide bioequivalence information on the clinical supplies of clopidogrel. The Medicines Co. said FDA did not ask for an additional trial for the indication. The advisory committee members voted against approval for the indication in part due to concerns with the design of CHAMPION PHOENIX.

For the bridging indication, FDA said the company should conduct another trial evaluating outcomes like bleeding that "can result in the clinical data necessary to assess the benefit-risk relationship." Panel members voted against the indication because there were not enough data on the proposed cangrelor dose for the indication. ...