Posted by Michael Wonder on 19 Sep 2023
Altuviiio supplemental biologics license application based on positive final results from Phase 3 XTEND-Kids study accepted by FDA
12 September 2023 - Final results from XTEND-Kids study were submitted for review, potentially expanding on the interim data included in the label at initial FDA approval.
The US FDA has accepted a supplemental biologics license application for Altuviiio [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl].
