Shots:

• The approval is based on 2 P-III studies i.e., (EINSTEIN-Jr) & (UNIVERSE) trial to evaluate rivaroxaban in 500 & 112 children aged birth to ≤18yrs. & ≥2yrs. with previously diagnosed VTE, following 5 days of initial parenteral anticoagulation treatment & CHD who have undergone Fontan procedure
• In (EINSTEIN-Jr) trial, the therapy showed a similar low risk of symptomatic recurrent VTE (1.2% vs 3.0% SoC), In (UNIVERSE) trial, 8.3% & 1.6% of patients in Part A & B experienced a thrombotic event over 8.8% with aspirin
• The therapy is available as oral suspension & tablet dosage forms for individuals aged ≥18 yrs. & oral suspension formulation is expected to be available in the US in mid-Jan 2022

Ref: PR Newswire | Image: Janssen