Shots:

• The application is based on two studies i.e P-III EINSTEIN-Jr & UNIVERSE. The P-III EINSTEIN-Jr study evaluates Xarelto in 500 children in a ratio (2:1) aged birth to 17yrs. with previously diagnosed VTE- following 5 days of initial parenteral anticoagulation treatment
• The P-III UNIVERSE study evaluates Xarelto in children aged 2-8yrs. with congenital heart disease who have undergone the Fontan procedure. Xarelto would be a body weight-adjusted dose with an oral suspension formulation or tablets for both indications
• If approved- Xarelto will be the first and only oral Factor Xa inhibitor indicated in the US for pediatric patients

  Ref: J&J | Image: Janssen