FDA Approves Rivaroxaban for Hospitalized Blood Clot Prevention


The new indication marks the sixth for treatment in venous thromboembolism with the direct oral anti-coagulant.

The US Food and Drug Administration (FDA) has approved rivaroxaban (XARELTO) for the prevention of venous thromboembolism (VTE)—or blood clots—in acutely ill hospitalized patients at risk for clotting complications without risk of bleeding.

With the indication, rivaroxaban has been approved for treatment in 8 different focuses, 6 being for the treatment, prevention, and reduction of VTE risk—more than any direct oral anticoagulant (DOAC) in the US.

The indication also allows for the initiation of rivaroxaban in patients during hospitalization, and to continue for blood clot treatment post-discharge for 31-39 days.

The benefit of rivaroxaban in acute medically ill patients with VTE was assessed in the 20,000-patient, phase 3 MAGELLAN and MARINER clinical program. Six years ago, MAGELLAN results showed rivaroxaban demonstrated non-inferiority to low-molecular-weight heparin enoxaparin in short-term use, and superiority in long-term use versus the comparator drug plus placebo. Combined rates of major and non-major clinically relevant bleeding were higher in rivaroxaban treatment arms, however.

In a recent interview with MD Magazine® discussing the benefit of rivoraxaban 2.5 mg in coronary artery disease and peripheral artery disease as evidenced in the COMPASS Trial, Deepak Bhatt, MD, detailed the bleeding risks associated with the DOAC therapy.

“Fortunately, we didn't see any significant excess in failure intracranial bleeding, but still do need to be cautious and not use this therapy in patients who are high risk of bleeding, be cautious in patients who are older, and who have other risk factors for bleeding,” Bhatt, executive director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital, said. “But in patients who have a low risk of bleeding, haven't had bleeding problems on aspirin, but remain at high ischemic risk—there, I think the addition of rivaroxaban 2.5 mg twice a day could be really useful to reduce future events.”

Alex C. Spyropoulos, MD, professor of Medicine at The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Northwell Health at Lenox Hill Hospital, explained the phase 3 MAGELLAN and MARINER programs showed the efficacious and safe benefits of 10 mg rivaroxaban in this particular patient population.

"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," Spyropoulos said in a statement.

James List, MD, PhD, global therapeutic area head for Cardiovascular & Metabolism at Janssen Research & Development, called blood clot prevention a "critical priority" for physicians treating patients with the potentially fatal condition. The indication also provides a new level of convenience to both physicians and patients.

"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," he explained.

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