- The P-III EINSTEIN-Jr. study involves assessing of Xarelto (20mg) vs SOC (heparins as monothx. or in combination with Vit.K antagonist like warfarin) in 500 children in ratio (2:1) with acute VTE who had started heparin therapy aged ≤ 17yrs.
- The P-III EINSTEIN-Jr. study results: VTE reoccurrence (1.2% vs 3.0%); improvement in thrombotic burden; bleeding episode [3% (all non-major bleeds) vs 1.9% (2 major & 1 non-major)]; safety profile is consistent to prior studies in adults
- Xarelto is a non-vitamin K antagonist oral anticoagulant (NOAC) and is approved for eight indications, jointly developed by Bayer & Janssen. Bayer plans to submit MAA to EMA for extension of the Xarelto, making it available for children with VTE
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