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· To date, no approved therapies have been used to treat and prevent venous thromboembolism in children. Current standard treatments require frequent monitoring of anticoagulants or daily injections. The positive evaluation is based on a dedicated pediatric clinical program for the Dabiga group, including the DIVERSITY study, which complements the clinical evidence profile of safety and efficacy in adults established by the Dabiga group, and recently announced that the European Medicines Agency's Human Medicines Committee (CHMP) has adopted a positive evaluation of the treatment of venous thrombosis events (VTE) and prevention of VTE resuscemia in children under 18 years of age.
If the submitted adaptation is approved by the European Commission (EC), pediatric patients and medical personnel will be able to use oral anticoagulant therapy, and the risk/benefit profile of the treatment has been fully assessed by health care providers.
Currently, there are no approved treatments for the treatment or prevention of intravenous blood clots (VCTs) in children, and current standard treatment methods (SOCs) have a number of limitations, including the need to monitor anticoagulant levels frequently or to bear the burden of daily injections.
positive opinion of CHMP is based on a dedicated paediatric clinical plan.
clinical study of DIVERSITY showed that in children with a higher risk of VTE, the Dabiga group was not inferior to the standard treatment, and the risk of bleeding was comparable.
studies have shown that the Dabiga group has good safety outcomes for children with VTE and risk factors for persistent thrombosis.
based on the results of relevant studies and the likely expansion of the patient population, this much-anticipated approval of the adaptation will be an important milestone for the Dabiga group.
note: There are deletions in the original text