FDA grants expanded indication for rivaroxaban related to PAD population
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Janssen Pharmaceuticals announced that the FDA has granted an expanded indication to rivaroxaban, now allowing it for use in patients who had recent lower-extremity revascularization due to symptomatic peripheral artery disease.
The approval is for rivaroxaban (Xarelto) 2.5 mg twice daily in conjunction with aspirin 100 mg once daily, according to a press release from the company.
According to the release, the new indication was granted based on results from the VOYAGER PAD trial, in which, as Healio previously reported, patients with symptomatic PAD who underwent lower-extremity revascularization had a lower incidence of major adverse limb and CV events when treated with low-dose rivaroxaban twice daily plus aspirin, compared with aspirin only.
Rivaroxaban now has nine indications, according to the release.
"For more than 20 years, many physicians have used dual antiplatelet therapy after lower extremity revascularization due to symptomatic PAD with limited data to support efficacy and safety in this setting. Now, the VOYAGER PAD and COMPASS clinical studies have demonstrated the utility of dual pathway inhibition in targeting both platelets and thrombin in patients with PAD. These data provide a new mechanism of treatment using an evidence-based strategy for this vulnerable population," Marc P. Bonaca, MD, MPH, associate professor of medicine, William R. Hiatt Endowed Chair in Cardiovascular Research and director of vascular research at University of Colorado Anschutz Medical Campus, Aurora, Colorado, said in the release. "This FDA approval of rivaroxaban plus aspirin is a major advancement for PAD management and sets the stage to evolve the current standard of care for patients with PAD."
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