Xarelto Approval For AF Stroke Risk Reduction Tested FDA’s Comparative Efficacy Powers, But Conservative View Prevailed

The primary reviewers of Johnson & Johnson/Bayer AGXarelto (rivaroxaban) for stroke risk reduction in atrial fibrillation patients argued that the still-recent approval of Boehringer Ingelheim Corp.’s Pradaxa (dabigatran) gave FDA grounds to demand comparative efficacy data to justify rivaroxaban’s approval. But the leadership of FDA’s Division of Cardiovascular and Renal Products cleared Xarelto on the basis of existing data, holding to a more limited view of what triggers the agency’s ability to require that comparative effectiveness be shown to alternative therapy.

Boehringer’s Pradaxa was cleared in October 2010 – months before the Xarelto submission for reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation but well after the clinical study was conducted