Janssen Reports Submission of NDA to the US FDA for Xarelto (rivaroxaban) to Prevent and Treat Blood Clots in Children

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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

Click here to read full press release/ article | Ref: J&J | Image: Fortune Italia