October 14, 2019

The U.S. FDA has approved a new indication for Xarelto ® (rivaroxaban), manufactured by Janssen Pharmaceutical, to prevent venous thromboembolism (VTE or blood clots) in acutely ill medical patients who are at risk for thromboembolic complications but not at high risk of bleeding.

More than seven million people in the US are hospitalized annually with acute medical illness. These patients have an increased risk of blood clots for up to three months following discharge from the hospital. In 80% of cases, thromboembolic complications occur within the first six weeks. Current treatment guidelines call for the use of anticoagulants in patients with acute medical illness who are risk of VTE, though research suggests patients may refuse such treatment—which is often provided using injectable medications—due to fear, discomfort, anxiety, or inconvenience.

In one clinical study, Xarelto demonstrated non-inferiority to the injectable anticoagulant Lovenox® (enoxaparin – Sanofi) in short-term use (10 ± 4 days), as well as superiority in long-term use (35 ± 4 days) compared to short-term use of Lovenox followed by placebo. In a second study, Xarelto significantly reduced symptomatic VTE with consistent and favorable safety compared to placebo alone.

Recommended dosing under the new indication is 10mg taken by mouth once daily, with or without food, in hospital and after hospital discharge for a total recommended duration of 31 to 39 days. A black box warning cautions that premature discontinuation of Xarelto increases the risk of thrombotic events. There is also a black box warning for spinal or epidural hematoma, which can lead to long-term and permanent paralysis, in patients being treated with Xarelto who receive neuraxial anesthesia or undergo spinal puncture.

First FDA approved in 2011, Xarelto holds seven indications for the treatment of prevention of blood clots or major cardiovascular events.

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