Sanofi seeks to strengthen Altuviiio case based on trial results
The US Food and Drug Administration (FDA) has accepted a supplemental biologics license application (sBLA) for Altuviiio [antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl].
This sBLA is based on positive final results from the Phase III XTEND-Kids study, which demonstrated highly effective bleed protection in children with severe hemophilia A with once-weekly dosing.
"A first-of-its-kind option with proven bleed protection and reduced treatment burden"The Prescription Drug User Fee Act (PDUFA) action date is May 10, 2024.
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