The FDA has approved Altuviiio™ (Sanofi) [Antihemophilic Factor (Recombinant), FcVWF-XTEN Fusion Protein-ehtl], previously referred to as efanesoctocog alfa, a first-in-class, highsustained factor VIII replacement therapy. This is the first approval of Altuviiio.
Altuviiio is indicated for routine prophylaxis and on-demand treatment to control bleeding episodes, as well as perioperative management (surgery) for adults and children with hemophilia A. It is the first and only hemophilia A treatment that delivers normal to near-normal factor activity levels (over 40%) for most of the week with once-weekly dosing, and significantly reduces bleeds compared to prior factor VIII prophylaxis. Altuviiio has a 3- to 4-fold longer half-life relative to standard and extended half-life factor VIII products.
Hemophilia A is a rare, lifelong condition in which the ability of a person’s blood to clot properly is impaired, leading to excessive bleeds and spontaneous bleeds into joints that can result in joint damage and chronic pain, and potentially impact quality of life.
The FDA evaluated the application under Priority Review, which is granted to therapies that have the potential to provide significant improvements in the treatment, diagnosis, or prevention of serious conditions. Regulatory submission in the EU is anticipated in the second half of 2023. The European Commission granted Orphan Drug designation in June 2019.
To ensure that patients have access to the improved bleed protection provided by Altuviiio, Sanofi will
price Altuviiio at parity to the annual cost of treating a prophylaxis patient on Eloctate® [Antihemophilic
Factor (Recombinant), Fc Fusion Protein].
Sobi and Sanofi have collaborated on the development and commercialization of Altuviiio™ in the US,
where it is expected to be commercially available in April.
