Clinical data | |
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Trade names | Altuviiio, Altuvoct |
Other names | BIVV001; antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl |
License data | |
Routes of administration | Intravenous |
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Chemical and physical data | |
Formula | C13690H20958N3682O4376S136 |
Molar mass | 311501.81 g·mol−1 |
Efanesoctocog alfa, sold under the brand name Altuviiio, is a medication used for the treatment of hemophilia A (congenital factor VIII deficiency). [1] [4]
Efanesoctocog alfa was approved for medical use in the United States in February 2023. [1] [4] [5] [6] [7]
Efanesoctocog alfa is a recombinant DNA-derived, Factor VIII concentrate indicated for use in adults and children with hemophilia A (congenital factor VIII deficiency) for routine prophylaxis to reduce the frequency of bleeding episodes; on-demand treatment & control of bleeding episodes; and perioperative management of bleeding. [1] [4]
In April 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Altuvoct, intended for the prevention and treatment of bleeding in people with hemophilia A caused by factor VIII deficiency. [2] [8] The applicant for this medicinal product is Swedish Orphan Biovitrum. [2] Altuvoct was approved for medical use in the European Union in June 2024. [3] [9]