Bayer announces expansion of anticoagulant Xarelto's indications
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Last Update: 2020-06-07
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Source: Internet
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Author: User
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Recently, Bayer announced that it will expand the adaptation of the anticoagulant Xarelto (rivaroxaban, Devashaban) for children under the age of 17 diagnosed with venous thrombosis (VTE), including sinus thrombosis (CVST)About Xarelto
Xarelto is the world's most widely used non-vitamin K antagonist oral anticoagulant (NOAC), has been approved for nine treatment synostics, with different country indicationsIn October 2019, Xarelto was approved by the U.SFDA(http://for the prevention of VTE for patients with inpatient acute medical conditions who are at risk of thrombosis complications but do not have a high hemorrhage riskXarelto was developed by Bayer and Johnson and Johnson and Johnson and the drug has been approved by more than 130 countries worldwideJohnson and Johnson is responsible for U.Ssales and Bayer is responsible for markets outside the U.SIn 2018, Xarelto's global sales reached $6.149 billion, up 9.02 percent from 2017 ($5.64 billion)In the study
children received Xarelto tablets or newly developed oral suspensionsThe results showed that Xarelto treated pediatric patients with similar recurrent VTE risk and similar low bleeding rates compared to current standard anticoagulant therapy, and their efficacy and safety were consistent with those previously observed in adult patients with VTE EINSTEIN-Jr is a randomized, open label Phase III study that enrolled 500 pediatric patients in a group diagnosed with acute VTE and have begun treatment with heparin (born to age 17) In the study, these pediatric patients received an open label, weight-adjusted dose Xarelto (n-335, tablet or suspension) or standard anticoagulant therapy (n-165, common heparin, low-molecular heparin, or sulfonida sodium hemolyphthograms (fondaparinux) or a conversion to vitamin K-resistance The duration of treatment is 3 months, but children under 2 years of age with catheter-related VTE receive 1 month of treatment Repeated imaging is performed at the end of treatment The main efficacy indicators in the study were symptomatic recurrent VTE (fatal or non-fatal), and the main safety results were a combination of severe bleeding and clinically related non-severe bleeding
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