Sobi™ receives approval from the European Medicines Agency for higher capacity drug substance manufacturing for Elocta®
Swedish Orphan Biovitrum AB (publ) (Sobi™) (STO:SOBI) has received approval from the European Medicines Agency (EMA) for the grouped type II 15 K Variation for Elocta® (efmoroctocog alfa). The variation involves several changes, including the approval of Elocta drug substance manufacturing in 15 000 litre scale bioreactors. Elocta is a recombinant extended half-life factor VIII