Efanesoctocog alfa

Last updated

Efanesoctocog alfa
Clinical data
Trade names Altuviiio, Altuvoct
Other namesBIVV001; antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl
License data
Routes of
administration 		Intravenous
ATC code
  • None
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, sold under the brand name Altuviiio, is a medication used for the treatment of hemophilia A (congenital factor VIII deficiency). [1] [4]

Contents

Efanesoctocog alfa was approved for medical use in the United States in February 2023. [1] [4] [5] [6] [7]

Medical uses

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]

Society and culture

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]

References

  1. 1 2 3 4 "Altuviiio (antihemophilic factor- recombinant, fc-vwf-xten fusion protein-ehtl kit". DailyMed. 31 March 2023. Retrieved 7 May 2023.
  2. 1 2 3 "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.
  3. 1 2 "Altuvoct PI". Union Register of medicinal products. 18 June 2024. Retrieved 26 June 2024.
  4. 1 2 3 "Altuviiio". U.S. Food and Drug Administration. 21 March 2023. Retrieved 7 May 2023.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  5. ↑ 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.
  6. ↑ "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.
  7. ↑ Keam SJ (July 2023). "Correction to: Efanesoctocog Alfa: First Approval". Drugs. 83 (10): 953. doi:10.1007/s40265-023-01901-9. PMC   10284942 . PMID   37268757.
  8. ↑ "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.
  9. ↑ "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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