Altuviiio FDA Approval History

Last updated by Judith Stewart, BPharm on July 15, 2024.

FDA Approved: Yes (First approved February 22, 2023)
Brand name: Altuviiio
Generic name: antihemophilic factor recombinant, Fc-VWF-XTEN fusion protein-ehtl
Previous name: efanesoctocog alfa
Dosage form: Lyophilized Powder for Injection
Company: Sanofi
Treatment for: Hemophilia A

Altuviiio [antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl] is a recombinant DNA-derived, factor VIII concentrate indicated for use in people with hemophilia A.

Altuviiio is 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
- perioperative management of bleeding.
  Limitation of Use: Altuviiio is not indicated for the treatment of von Willebrand disease.
Hemophilia A is an inherited disorder in which a person’s blood does not clot properly due to a deficiency or insufficiency of a clotting protein called factor VIII. It can lead to uncontrolled and often spontaneous bleeding. Treatment involves replacing the missing clotting factor.
Altuviiio is designed to deliver normal to near-normal factor activity levels (over 40%) for most of the week with once-weekly dosing, and has been shown to significantly reduce bleeds compared to prior factor VIII prophylaxis.
Altuviiio is administered via intravenous injection once weekly for routine prophylaxis, and on-demand for treatment and control of bleeding episodes and perioperative management.
Warnings and precautions associated with Altuviiio include hypersensitivity reactions (including anaphylaxis) and formation of neutralizing antibodies (inhibitors) to factor VIII.
Common adverse reactions include headache and arthralgia.

Development timeline for Altuviiio

Date	Article
May 10, 2024	Approval FDA Approves Updated Altuviiio Label With Expanded Pediatric Data Confirming Highly Effective Bleed Protection in Children With Hemophilia
Feb 23, 2023	Approval FDA Approves Altuviiio ([Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl]) Once-Weekly VIII Therapy for Hemophilia A
Jan 26, 2023	NEJM publishes data demonstrating clinically meaningful prevention of bleeds and superior bleed protection for efanesoctocog alfa
Aug 30, 2022	FDA Grants Priority Review to Efanesoctocog Alfa for People with Hemophilia A
Jul 10, 2022	Pivotal Data Demonstrate Once-Weekly Efanesoctocog Alfa Provides Superior Bleed Protection Compared to Prior Factor Prophylaxis
Jun 1, 2022	FDA Grants Efanesoctocog Alfa Breakthrough Therapy Designation for Hemophilia A
Mar 9, 2022	Efanesoctocog Alfa Met Primary And Key Secondary Endpoints in Pivotal Study in Hemophilia A, Demonstrating Superiority To Prior Factor Prophylaxis Treatment
Feb 18, 2021	Efanesoctocog Alfa Granted FDA Fast Track Designation for Treatment of Hemophilia A

Further information

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Medical Disclaimer

Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

Altuviiio FDA Approval History

Development timeline for Altuviiio

See also

Further information