Anticoagulation therapy for children! Bayer submits Xarelto application

The application is based on the results of Phase III clinical studies EINSTEIN-JrThe study is the largest pediatric study ever conducted for VTE therapy and the first to evaluate a direct oral anticoagulant for a group of children under 17 years of ageIn 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 VTEEINSTEIN-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-resistanceThe duration of treatment is 3 months, but children under 2 years of age with catheter-related VTE receive 1 month of treatmentRepeated imaging is performed at the end of treatmentThe 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 bleedingIn early July, the results from the EINSTEIN-Jr study were announced at the 27th International Society for Thrombosis and Hemorrhagic Society (ISTH2019) 2019 in Melbourne, AustraliaThe results showed that the study reached all pre-specified endpoints: (1) recurrent VTE events were similar in 2 groups, and the Xarelto treatment group was slightly lower numerically (recurrent VTE event incidence rate: 1.2% (n?4) vs 3.0% (n?5) AND HR?0.40, 95% CI: 0.11-1.41), and both treatment groups were non-lethal VTE events(2) 2 groups of clinically related hemorrhage were similar, with the incidence of Xarelto treatment group and standard anticoagulant group being 3.0% (n-10, both non-hemorrhage) and 1.9% (n-3, 2 cases of haemorrhage and 1 case of non-hemorrhage) (HR-1.58,95% CI:0.51-6.27)(3) In terms of recurrent VTE and haemorrhagic compound endpoint (net clinical benefit), the incidence of Xarelto treatment group was 1.2% and the incidence of standard anticoagulant group was 4.2% (HR -0.30, 95% CI: 0.08-0.93)(4) Repeated imaging at the baseline and at the end of the treatment period showed that Xarelto's improvement effect on thrombosis burden was better than standard anticoagulant therapy (p-0.012): the initial VTE total elimination rate, the Xarelto treatment group was 38.5% and the standard anticoagulant group was 26.1% (total response: 1.72, 95% CI: 1.12-2.69)VTE affects people of all ages, and current treatment of VTE in children often relies on intravenous anticoagulants and requires laboratory monitoring and dose adjustmentSo far, anticoagulant treatment programmes in children have been based mainly on the extrapolation of observational data and adult dataThe EINSTEIN-Jr study represents a major advance in pediatric VTE therapy Xarelto is the world's most widely used non-vitamin K antagonist oral anticoagulant (NOAC), and has been approved for nine treatments for indications, with different country indications Compared to other NOACs, Xarelto can help a wide range of patients to prevent a wide range of venous thrombosis (VTE) and arterial thrombosis (VAT) diseases In October, Xarelto was approved by the U.S FDA to prevent VTE for hospitalized patients with a risk of thrombosis complications but no risk of high bleeding With the approval of this new indication, Xarelto treatment can be initiated for these patients during hospitalization and continued after discharge, with a total recommended duration of 31-39 days Xarelto, developed by Bayer and Johnson and Johnson, has been approved by more than 130 countries around the world Johnson and Johnson is responsible for U.S sales and Bayer is responsible for markets outside the U.S In 2018, Xarelto's global sales reached $6.149 billion, up 9.02 percent from 2017 ($5.64 billion) original origin: Bayer submits application to EMA for use of rivaroxaban in the children with the tha venous thrombolism