FDA Advisory Panel Recommends Approval of New Xarelto Indication

A Food and Drug Administration advisory panel Sept. 9 voted to recommend that FDA approve Xarelto (rivaroxaban) for prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF).

The Cardiovascular and Renal Drugs Advisory Committee voted 9-2, with one abstention, in favor of the drug’s approval for this indication, an FDA spokeswoman told BNA Sept. 9. Xarelto is being developed jointly by Johnson & Johnson Pharmaceutical Research and Development LLC (J&JPRD) and Bayer HealthCare AG.

“We are pleased with the committee’s recommendation and look forward to working with the FDA to help make this important therapy available ...