The Ministry of Food and Drug Safety has allowed BMS Korea to conduct a phase-3 trial of Eliquis (ingredient: apixaban), an anticoagulant jointly developed by BMS and Pfizer, on pediatric patients in Korea.
|BMS’ anticoagulant Eliquis|
The study will be on children newly diagnosed with acute lymphoblastic leukemia (ALL) or lymphoma (T cells or B cells). It will compare the safety and efficacy of Eliquis on one group to prevent thromboembolism during remission-inducing chemotherapy that includes asparaginase with the other group of those untreated with Eliquis.
The multicenter, international, randomized, and open trial will be on 500 patients around the world including 20 at Seoul National University Hospital and Severance Hospital in Korea.
Eliquis touched down the domestic market in July 2013 and sold 33.2 billion won last year, according to UBIST’s preliminary data.
Eliquis’ indications include prevention of venous thromboembolism in adults who had a hip or knee replacement surgery, reduction in risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, treatment of deep venous thrombosis and pulmonary embolism, and reduction of recurrence risk of deep vein thrombosis and pulmonary embolism.
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