Sonofi and Sobi have secured the approval of the US Food and Drug Administration (FDA) for their Altuviiio [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl] for hemophilia A treatment.

Altuviiio, previously known as efanesoctocog alfa, is a first-in-class, high-sustained factor VIII replacement therapy indicated for routine prophylaxis and on-demand treatment to control bleeding episodes, as well as perioperative management (surgery) for adults and children with hemophilia A.

Paul Hudson — Sanofi CEO, commenting on Altuviiio FDA approval, said: “Today’s approval of ALTUVIIIO allows patients and physicians to reimagine living with hemophilia.

“The high sustained factor activity levels that can be achieved with ALTUVIIIO have the potential to change the hemophilia landscape.

“For the first time, with a once-weekly dose, powerful bleed protection is a reality for patients.

“Significant shifts in treatment paradigms that improve people’s lives, like ALTUVIIIO, are what we have committed to delivering at Sanofi.”

The approval by the FDA was backed by the findings of XTEND-1 phase 3 study in which Altuviiio showed superiority to prior factor prophylaxis treatment based on an intra-patient comparison.

In the study, Altuviiio prophylaxis provided substantial bleed protection for people with severe hemophilia A with a mean annualized bleeding rate (ABR) of 0.7 and a median ABR of 0.0.

Moreover, interim data from XTEND-Kids demonstrated that children younger than 12 years of age receiving once-weekly Altuviiio for 26 weeks experienced a mean ABR of 0.5 and a median ABR of 0.

Altuviiio is expected to be commercially available in April in the US, with regulatory submission in the European Union (EU) anticipated to occur in the second half of 2023.

Sanofi and Sobi have partnered to develop and commercialize Altuviiio in the US.

Sobi has final development and commercialization rights in the Sobi territory, mainly Europe, North Africa, Russia, and most Middle Eastern markets.

Sanofi has final development and commercialization rights in North America and all other regions globally, not including the Sobi territory.

  Altuviiio, efanesoctocog alfa, Hemophilia A, Paul Hudson, Sanofi, Sobi, US FDA, US Food and Drug Administration, USA