US FDA grants eighth indication for Xarelto

The  Food and Drug Administration 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, says Johnson & Johnson (NYSE: JNJ) pharma subsidiary Janssen, which has US marketing rights to the drug from Germany’s Bayer (BAYN: DE).

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, 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. Xarelto generated sales of $2.48 billion in 2018 for the US firm.

Importance of oral-only option