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Bayer Reports Submission of MAA to EMA for Rivaroxaban to Treat Venous Thromboembolism in Children

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Bayer Reports Submission of MAA to EMA for Rivaroxaban to Treat Venous Thromboembolism in Children

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  • Bayer has submitted MAA to EMA based on P-III EINSTEIN-Jr. study evaluating Rivaroxaban vs SOC in 500 children in a ratio (2:1) aged from birth to 17yrs. with documented acute VTE who had started heparin therapy
  • The P-III EINSTEIN-Jr. study results: patients with recurrent VTE (1.2% vs 3.0%)- the occurrence of bleeding [10 (all non-major) vs 3 (two major and one non-major)- repeat imagining demonstrated an improved effect on the thrombotic burden. Bayer will apply for a patent extension of six mos. following the completion of the procedure- extending its patent period to Apr’2024
  • Xarelto is the only non-vitamin K antagonist oral anticoagulant (NOAC)- jointly developed by Bayer & Janssen and is approved in the US for the continuum of VTE care- from prevention and treatment of initial VTE via extended prevention of recurrent VTE

Click here to­ read full press release/ article | Ref: Bayer | Image: Behance


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