1. Pink Sheet

Xarelto Tested FDA’s Comparative Efficacy Powers, But Conservative View Prevailed

 
• By Bridget Silverman

J&J/Bayer’s Xarelto tested the limits of FDA’s policy on comparative efficacy, thanks to suboptimal use of the active comparator, warfarin, and the introduction of a new competitor, Pradaxa. In the medical reviewers’ view, new therapies should be as effective as existing therapies used skillfully, but division leadership would withhold approval only if the new drug were clearly inferior to approved agents.

The primary reviewers of Johnson & Johnson/Bayer AGXarelto (rivaroxaban) 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

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Clinical Trials

More from R&D