Rivaroxaban (Xarelto) Picks Up New VTE Indication in Acutely Ill

Patrice Wendling

October 14, 2019

The US Food and Drug Administration (FDA) has approved a new indication for the oral anticoagulant rivaroxaban (Xarelto) for the prevention of venous thromboembolism (VTE) in hospitalized acutely ill medical patients at risk for thromboembolic complications but not at high risk of bleeding.

Rivaroxaban can now be initiated for these patients during hospitalization and continued after discharge for a total recommended duration of 31 to 39 days, Janssen Pharmaceuticals/Johnson & Johnson says in its news release.

"With this new approval, Xarelto as an oral-only option now has the potential to change how acutely ill medical patients are managed for the prevention of blood clots, both in the hospital and for an extended period after discharge," Alex C. Spyropoulos, MD, the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Northwell Health at Lenox Hill Hospital, New York City, NY, says in the release.

Guidelines currently recommend that acutely ill medical patients at risk for VTE receive anticoagulants, typically injectable agents, in the hospital to protect them from blood clots, but advise against routine anticoagulant use after leaving the hospital, the company notes.

The new indication was based on the phase 3 MAGELLAN and MARINER studies. As previously reported, the 2013 MAGELLAN study in acutely ill patients showed rivaroxaban to be noninferior to standard 10-day treatment with subcutaneous enoxaparin for the prevention of asymptomatic proximal or symptomatic VTE at day 10 and superior to enoxaparin for the prevention of the same clinical events at day 35.

The 2018 MARINER study failed to show a significant benefit of rivaroxaban over placebo in reducing the composite end point of symptomatic VTE or death in medically ill patients at increased risk for VTE after discharge; although there were few events and the primary safety outcome, major bleeding, was not significantly increased with treatment.

To date, the FDA has granted rivaroxaban eight indications, six of which are specifically for the treatment, prevention, and reduction of VTE recurrence across a wide range of patient populations, the company notes.

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