Efanesoctocog alfa explained

Tradename:	Altuviiio, Altuvoct
Dailymedid:	Altuviiio
Routes Of Administration:	Intravenous
Atc Prefix:	None
Legal Us:	Rx-only
Legal Us Comment:	^[1]
Legal Eu:	Rx-only
Legal Eu Comment:	^[2]
Cas Number:	2252477-42-0
Drugbank:	DB16662
Unii:	WH7BHQ0RB4
Kegg:	D12441
Synonyms:	BIVV001; antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl
C:	13690
H:	20958
N:	3682
O:	4376
S:	136

Efanesoctocog alfa, sold under the brand name Altuviiio, is a medication used for the treatment of hemophilia A (congenital factor VIII deficiency).

Efanesoctocog alfa was approved for medical use in the United States in February 2023.^{[3] [4]}

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.^[5]

Society and culture

Legal status

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.^[6] The applicant for this medicinal product is Swedish Orphan Biovitrum AB (publ).^[7] Altuvoct was approved for medical use in the European Union in June 2024.^[8]

Notes and References

1. Web site: Altuviiio (antihemophilic factor- recombinant, fc-vwf-xten fusion protein-ehtl kit . DailyMed . 31 March 2023 . 7 May 2023.
2. Web site: Altuvoct PI . Union Register of medicinal products . 18 June 2024 . 26 June 2024.
3. AB . Swedish Orphan Biovitrum . FDA approves once-weekly efanesoctocog alfa, a new class of high-sustained factor VIII therapy for haemophilia A: Swedish Orphan Biovitrum AB . Swedish Orphan Biovitrum AB . PR Newswire . 24 February 2023 . 7 May 2023.
4. Press Release: FDA approves once-weekly Altuviiio, a new class of factor VIII therapy for hemophilia A that offers significant bleed protection . Sanofi . 23 February 2023 . 7 May 2023.
5. Web site: Altuviiio . U.S. Food and Drug Administration . 21 March 2023 . 7 May 2023.
6. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2024 . European Medicines Agency . 26 April 2024 . 13 June 2024.
7. Web site: Altuvoct EPAR . . 25 April 2024 . 27 April 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
8. European Commission grants Sobi Marketing Authorisation for Altuvoct for treatment of haemophilia A . Swedish Orphan Biovitrum AB . PR Newswire . 19 June 2024 . 26 June 2024.