perform an assay that measures Factor VIII inhibitor concentration. Monitor plasma FVIII activity using a chromogenic assay or one-stage clotting assay. If one-stage clotting assay is used ...

with hemophilia A or B with or without factor VIII or IX inhibitors. The approval is based on data from the ATLAS phase 3 studies that demonstrated clinically meaningful bleed protection as measured ...

with or without factor VIII or IX inhibitors (neutralizing antibodies). "Today's approval of Qfitlia is significant for patients with hemophilia because it can be administered less frequently than ...

Sanofi’s Qfitlia (fitusiran) has been approved by the US Food and Drug Administration (FDA) as the first therapy to treat haemophilia A or B regardless of inhibitor status.

with hemophilia A or B with or without factor VIII or IX inhibitors. The approval is based on data from the ATLAS phase 3 studies that demonstrated clinically meaningful bleed protection as ...

Qfitlia (fitusiran), an siRNA drug to treat the frequency of bleeding episodes in adult and pediatric patients with hemophilia A or B, gets FDA approval.