Janssen Announces U.S. FDA Approval for XARELTO® (rivaroxaban) to Help Prevent Blood Clots in Acutely Ill Medical Patients

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that 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. 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.

“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,” said Alex C. Spyropoulos, M.D., Professor of Medicine, The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Northwell Health at Lenox Hill Hospital, New York, NY.[1] “The Phase 3 clinical studies in this high-risk patient group show us that XARELTO® at the 10mg dose is an effective and safe option to help prevent blood clots.”

More than seven million Americans are hospitalized each year with an acute medical illness, which is a broad term used to describe serious, yet common, medical conditions.[i] These patients are at increased risk of blood clots for up to three months after hospital discharge, with 80 percent of events happening within the first six weeks.[ii],[iii] In response to the burden of VTE in hospitalized patients, the Surgeon General issued a Call to Action in 2008 for key stakeholders to build a coordinated plan that could lead to a reduction in VTE across the U.S.[iv] 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.[v]

Guidelines currently recommend that acutely ill medical patients at risk of 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.[vi],[vii] Research shows that many patients refuse treatment with injectable anticoagulants out of fear, discomfort, anxiety or inconvenience.[viii]

“Preventing blood clots is a critical priority for physicians treating patients with acute medical illnesses, which is why Janssen is pleased that the FDA approved the use of XARELTO® to address this often fatal, yet preventable condition,” said James List, M.D., Ph.D., Global Therapeutic Area Head, Cardiovascular & Metabolism, Janssen Research & Development, LLC. “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.”

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