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FDA approves Xarelto to prevent blood clots in acutely ill hospitalized patients
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The FDA approved rivaroxaban for the prevention of venous thromboembolism among acutely ill hospitalized patients who are at risk for blood clots but not at high risk for bleeding, according to a press release from the agent’s manufacturer.
The approval indicates rivaroxaban (Xarelto, Janssen) — a direct oral anticoagulant — can be initiated for these patients during hospitalization and continued after discharge for a total duration of 31 to 39 days.
“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,” 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, said in the press release. “The phase 3 clinical studies in this high-risk patient group show us that Xarelto at the 10 mg dose is an effective and safe option to help prevent blood clots.”
The phase 3 clinical program for rivaroxaban included more than 20,000 patients with acute medical illnesses.
In the MAGELLAN study, researchers evaluated the use of rivaroxaban to prevent VTE in hospitalized patients — both during their stay and through discharge — who had an acute medical illness and restricted mobility. Results showed rivaroxaban achieved noninferiority to enoxaparin, a low-molecular-weight heparin, in short-term (10 ± 4 days) and long-term use (35 ± 4 days).
Combined rates of major and nonmajor clinically relevant bleeding appeared higher in the rivaroxaban group. However, a post-hoc analysis that applied five additional exclusionary criteria to eliminate patients at high risk for bleeding showed a favorable benefit-risk profile of rivaroxaban.
In the MARINER trial, researchers evaluated rivaroxaban compared with placebo to prevent VTE and VTE-related death following hospital discharge among acutely ill medical patients. Results showed rivaroxaban significantly reduced symptomatic VTE with a favorable safety profile, although the study did not meet its composite endpoint of a reduction in VTE and VTE-related death.
“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,” James List, MD, PhD, global therapeutic area head of cardiovascular and metabolism at Janssen Research & Development LLC, said in the press release. “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.”