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

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  • Janssen Pharmaceutical, a unit of Johnson & Johnson JNJannounced 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.
  • Price Action: JNJ stock is down 0.72% at $163.17 during the market session on the last check Monday.
Posted In: BiotechNewsHealth CareGeneralBriefsPhase 3 Trial
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