FDA Expands Rivaroxaban’s Indication to Include Hospitalized Patients

The U.S. Food and Drug Administration (FDA) approved the direct oral anticoagulant rivaroxaban for the prevention of venous thromboembolism (VTE) in hospitalized, acutely ill medical patients at risk for thromboembolic complications who are not at high risk of bleeding.

The agency’s decision was based on a review of data from the phase III MAGELLAN and MARINER trials. In MAGELLAN, which enrolled hospitalized patients with an acute medical ill-ness and restricted mobility, rivaroxaban was noninferior to enoxaparin in preventing VTE with short-term use (10±4 days) and superior to enoxaparin plus placebo in long-term use (35±4 days).

In the MARINER trial, which enrolled a similar population of acutely ill medical patients, rivaroxaban failed to meet its primary endpoint of lowering the risk of symptomatic VTE and VTE-related death. However, rivaroxaban appeared to reduce nonfatal symptomatic events, compared with placebo.

The approval indicates that rivaroxaban can be administered during hospitalization, then continued after discharge, for a total recommended duration of 31 to 39 days.

Source: Janssen press release, October 14, 2019.