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.
Related news and insights
Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group), announced that Health Canada has approved Ferriprox (deferiprone) for the treatment of iron overload in patients with sickle cell disease (SCD) or other anemias.
The Menarini Group and Radius Health announced positive topline results from the phase III EMERALD study evaluating RAD 1901 (elacestrant) as a monotherapy versus the standard of care (SoC) for the treatment of ER+/HER2- advanced or metastatic breast cancer (mBC).
Gilead Sciences, Inc. announced the FDA approved a new low-dose tablet dosage form of Biktarvy (bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15 mg tablets) for pediatric patients weighing at least 14 kg to less than 25 kg who are virologically suppressed or new to antiretroviral therapy.