- (PLX AI) – Bayer publishes new data for rivaroxaban in patients following the Fontan procedure and at risk for blood clots and blood clot related events.
- • Data from the Phase 3 UNIVERSE study found that treatment with Xarelto (rivaroxaban), in an oral suspension formulation, compared to treatment with aspirin, was associated with numerically fewer blood clots and clinical events strongly associated with blood clots in pediatric patients (aged 2-8 years) who have undergone the Fontan procedure
- • Study was included in a recent New Drug Application to the U.S. Food and Drug Administration for Xarelto
- • The study also found that treatment with Xarelto was associated with a similar safety profile compared to aspirin
- • A comparable and low prevalence of bleeding events in both treatment arms was observed