Swedish Orphan Biovitrum (Sobi) has received the European Commission (EC) marketing authorisation for Altuvoct to treat and prevent bleeds and perioperative prophylaxis in haemophilia A.

Altuvoct (efanesoctocog alfa), previously known as BIVV001, is a high-sustained factor VIII replacement therapy intended for all ages and any disease severity.

Sobi said that Altuvoct is the first high-sustained FVIII replacement therapy that can deliver near-normal factor activity levels for a significant part of the week, in people with haemophilia A.

It is the only therapy that has been shown to break through the von Willebrand factor ceiling, which imposes a half-life limitation on current factor VIII therapies, said the Swedish company.

Altuvoct was first approved in the US in February last year, following the US Food and Drug Administration (FDA) Breakthrough Therapy designation granted in May 2022.

It also received FDA Fast Track designation in 2021, and Orphan Drug designation in 2017.

Sobi chief medical officer and research, development, and medical affairs head Lydia Abad-Franch said: “Today’s announcement marks a major step forward in haemophilia care, offering the potential to significantly improve treatment outcomes and quality of life.

“For the first time, factor VIII activity levels can be sustained for a significant part of the week with simplified once-weekly dosing.

“We are proud to work alongside the haemophilia community, as we lead the paradigm shift towards normal haemostasis and create new possibilities together.”

Sobi developed Altuvoct in collaboration with French pharmaceutical company Sanofi.

The Swedish company holds the final development and commercialisation rights in Europe, North Africa, Russia, and most Middle Eastern markets.

Sanofi holds the rights in North America and all other regions excluding the Sobi territory.

The EC authorisation was based on the Phase 3 XTEND-1 study in adults and adolescents and XTEND-Kids in children, which evaluated the efficacy and safety of Altuvoct in people with severe haemophilia A.

In the studies, once-weekly Altuvoct prophylaxis (50 IU/kg) offered significant bleed protection for people of any age.

The study results showed substantial improvement in joint health, physical health, pain, and overall quality of life compared to baseline assessments at week 52.