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

Shots:

• 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

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