Phase III data on Kovaltry (recombinant Factor VIII) in haemophilia published online- Bayer HealthCare
New Phase III data from Bayer HealthCare's LEOPOLD Kids clinical trial investigating the safety and efficacy of BAY 81-8973, otherwise known as Kovaltry (recombinant Factor VIII) in previously treated children were published online in Haemophilia, the official peer-reviewed journal of the World Federation of Hemophilia. LEOPOLD Kids is a two-part, open-label, non-randomized phase III study.
Part A was designed to evaluate the efficacy and safety of BAY 81-8973 for prophylaxis, treatment of bleeds, and surgical management in previously treated children 12 years of age and younger, using regimens of two times or three times per week or every other day. Part B of the study, which involves previously untreated patients (PUPs), is ongoing. Bayer has submitted marketing applications for BAY 81-8973 in several countries, including the USA.
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