Sobi’s Altuvoct gains approval from MHRA

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Altuvoct (efanesoctocog alfa) to be used to treat and prevent bleeding in patients aged two years and above with severe or moderate hemophilia A.

The new marketing authorization was granted to Swedish Orphan Biovitrum (STO: SOBI), the Nordic biotech company also known as Sobi, and adds to the authorization of the drug by the European Commission in June last year.

Efanesoctocog alfa was approved by the US Food and Drug Administration under the brand name Altuviiio in 2023. French pharma major Sanofi (Euronext: SAN) and Swedish Orphan Biovitrum are co-developing and commercializing the therapy, with the former holding rights in the USA.