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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.

 

 

 

 

 

Development timeline for Altuviiio

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

Further information

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