Russia’s Health Ministry has granted a registration certificate to Swedish Orphan Biovitrum (Sobi), a rare disease drug specialist, for Altuvoct (efanesoctocog alfa), according to the state drug registry. The drug is indicated for the treatment and prevention of bleeding in adults and children aged two years and older with haemophilia A. It is the first product with this active ingredient to be registered in the country.
Altuvoct will be manufactured as a lyophilisate for solution for intravenous injection in four dosages: 1,000, 2,000, 3,000 and 4,000 IU, the registry shows. The Russian subsidiary of the Swiss company will handle registration and sales in Russia. Production is distributed among Sobi’s partners: US‑based Biogen synthesises the active pharmaceutical ingredient, Ireland’s Genzyme Ireland Limited produces the finished dosage form, and Genzyme and Germany’s Vetter Pharma-Fertigung handle packaging and filling.
Efanesoctocog alfa was originally developed by US‑based Bioverativ, a specialist in haemophilia and rare disease drugs. In 2018, France’s Sanofi acquired Bioverativ for $11.6 billion and brought in Sobi to continue development and commercialisation. The drug received FDA approval in 2023 and European approval in 2024.
In August 2025, the board of the Circle of Kindness foundation added efanesoctocog alfa to its procurement list, shortly after haemophilia A was included among the diseases funded by the state foundation. According to the foundation, seven patients have received Altuvoct since August 2025.
In 2020, Sobi and Skopinfarm signed an agreement to gradually localise production of the haemophilia drug efmoroctocog alfa at the Russian company’s plant in the Ryazan region, it was reported at the time.
