Efanesoctocog alfa, sold under the brand name Altuviiio, is a medication used for the treatment of hemophilia A (congenital factor VIII deficiency).[1][4]
| Clinical data | |
|---|---|
| Trade names | Altuviiio, Altuvoct |
| Other names | BIVV001; antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl |
| License data | |
| Routes of administration | Intravenous |
| ATC code |
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| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C13690H20958N3682O4376S136 |
| Molar mass | 311501.81 g·mol−1 |
Efanesoctocog alfa was approved for medical use in the United States in February 2023.[1][4][5][6]
Medical uses
editEfanesoctocog 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]
Society and culture
editLegal status
editIn 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][7] 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][8]
References
edit- ^ a b c d "Altuviiio (antihemophilic factor- recombinant, fc-vwf-xten fusion protein-ehtl kit". DailyMed. 31 March 2023. Retrieved 7 May 2023.
- ^ a b c "Altuvoct EPAR". European Medicines Agency. 25 April 2024. Retrieved 27 April 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ a b "Altuvoct PI". Union Register of medicinal products. 18 June 2024. Retrieved 26 June 2024.
- ^ a b c "Altuviiio". U.S. Food and Drug Administration. 21 March 2023. Retrieved 7 May 2023.
This article incorporates text from this source, which is in the public domain.
- ^ AB SO (24 February 2023). "FDA approves once-weekly efanesoctocog alfa, a new class of high-sustained factor VIII therapy for haemophilia A: Swedish Orphan Biovitrum AB" (Press release). Swedish Orphan Biovitrum AB. Retrieved 7 May 2023 – via PR Newswire.
- ^ "Press Release: FDA approves once-weekly Altuviiio, a new class of factor VIII therapy for hemophilia A that offers significant bleed protection" (Press release). Sanofi. 23 February 2023. Retrieved 7 May 2023.
- ^ "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2024". European Medicines Agency (Press release). 26 April 2024. Retrieved 13 June 2024.
- ^ "European Commission grants Sobi Marketing Authorisation for Altuvoct for treatment of haemophilia A" (Press release). Swedish Orphan Biovitrum AB. 19 June 2024. Retrieved 26 June 2024 – via PR Newswire.
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