Posted by Michael Wonder on 14 May 2024
FDA approves updated Altuviiio label with expanded paediatric data confirming highly effective bleed protection in children with haemophilia A
10 May 2024 - Full results from the pivotal XTEND-Kids study added to the US label, building on the interim data included in the 2023 FDA approval.
The US FDA has updated the label for Altuviiio [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl] to include full results from the Phase 3 XTEND-Kids study showing that once-weekly dosing with ALTUVIIIO delivers highly effective bleed protection in children with haemophilia A.
