FDA staff divided on approval of The Medicines Company's anticoagulant cangrelor

In documents released Monday ahead of an FDA advisory panel meeting on February 12, agency reviewers appeared split on whether The Medicines Company's experimental anticoagulant cangrelor should be approved for the prevention of cardiovascular events in patients undergoing percutaneous coronary intervention (PCI). The FDA accepted the drugmaker's marketing application for the intravenous therapy in July 2013.

The Medicines Company reported results from the Phase III CHAMPION PHOENIX trial in March last year showing that cangrelor was associated with a 22-percent lower risk of death, heart attack, repeat procedure or stent thrombosis than those who received Sanofi and Bristol-Myers Squibb's Plavix (clopidogrel), as well as a 38-percent lower risk of stent thrombosis alone. While FDA staff members Fred Senatore and B. Nhi Beasley said that cangrelor should be approved, as it met the main goals of the trial, reviewer Thomas Marciniak recommended against clearance of the therapy, arguing that the drug was not as good as or superior to Plavix.

Specifically, Marciniak questioned the conduct of the CHAMPION PHOENIX study as well as the trial's data analysis. In the study, which followed two Phase III trials that were halted after an interim analysis revealed that the primary endpoints would not be reached, The Medicines Company attempted to distinguish between heart attacks linked to cangrelor and those caused by PCI. "While the trials did not demonstrate convincingly superiority of cangrelor efficacy, they do demonstrate an increased risk of bleeding," Marciniak commented, adding that an additional study should be conducted before the therapy should be considered for approval.

Commenting on the FDA review, Leerink analyst Joseph P. Schwartz remarked that Marciniak's recommendation "should not come as a surprise given...his history of negativity." Meanwhile, Adnan Butt of RBC Capital Markets suggested that Marciniak's remarks have set the tone for the therapy's rejection by the FDA, noting that in the CHAMPION PHOENIX study, Plavix "was given too late in the control group to optimise its benefit." Butt added that if cangrelor "is approved...for [the] treatment of coronary disease, the product will be much more expensive than comparable agents with no superiority in efficacy or safety." If authorised, analysts expect The Medicines Company's drug to generate sales of about $226 million by 2018.

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