Janssen gets FDA’s green light for Xarelto for prevention of blood clots

The U.S. Food and Drug Administration (FDA) has approved Xarelto (rivaroxaban) for the prevention of venous thromboembolism (VTE), or blood clots, in hospitalized acutely ill medical patients at risk for thromboembolic complications who are not at high risk of bleeding, Janssen said Monday in a press release.

Janssen said that, with the approval of this new indication, Xarelto can be initiated for these patients during hospitalization and continued after discharge for a total recommended duration of 31 to 39 days. To date, Janssen noted in the press release, the FDA has granted Xarelto eight indications – the most of any direct oral anticoagulant (DOAC) – six of which are specifically for the treatment, prevention and reduction in the risk of recurrence of VTE across a wide range of patient populations.

Alex C. Spyropoulos, Professor of Medicine, The Donald and Barbara Zucker School of Medicine, New York, said that the Phase 3 clinical studies in this high-risk patient group show that Xarelto at the 10mg dose is an effective and safe option to help prevent blood clots.

However, a recent study found that in-hospital VTE rates continue to rise and more work is needed to reduce the burden of VTE especially among those at lower risk.

Janssen pointed out that the search shows that many patients refuse treatment with injectable anticoagulants out of fear, discomfort, anxiety or inconvenience.

James List, Global Therapeutic Area Head, Cardiovascular & Metabolism, Janssen Research & Development, LLC. said that, rather than facing daily injections with older anticoagulants, patients now have a new oral treatment option that will help prevent blood clots, both in the hospital and after hospital discharge.