Continued benefit demonstrated with BAY 81-8973 prophylaxis in previously treated children with severe haemophilia A: Interim analysis from the LEOPOLD Kids extension study

摘要

Introduction: BAY 81-8973 (Kovaltry (R)), a recombinant factor VIII (rFVIII) product, was efficacious and well tolerated in paediatric previously treated patients (PTPs) with severe haemophilia A for >= 50 exposure days (EDs) in the LEOPOLD Kids study. Because long-term prophylaxis (>= 100 EDs) can provide substantial patient benefits, FVIII products should demonstrate long-term safety and efficacy.