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

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

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

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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