J&J's Xarelto Tops Aspirin With Fewer Blood Clots In Pediatric Patients

Janssen Pharmaceutical, a unit of Johnson & Johnson JNJ, announced new data from the Phase 3 UNIVERSE study comparing Xarelto (rivaroxaban).
The data showed that Xarelto in an oral suspension formulation, compared to aspirin, was associated with fewer blood clots than aspirin in patients ages 2-8 who have had the Fontan procedure.
The Fontan procedure is performed in children with congenital heart disease who have a single functioning ventricle to redirect blood flow to the lungs to be reoxygenated.
The findings were published this month in the Journal of the American Heart Association and were included in a recent New Drug Application submitted to the U.S. Food and Drug Administration.
Data also found that Xarelto treatment was associated with a similar safety profile compared to aspirin.
The data is from two Phase 3 trials: one examined pediatric patients with previously diagnosed blood clots and the other evaluated pediatric patients at risk of blood clots after the Fontan procedure.
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