Sobi nets EMA’s approval for higher capacity drug substance for Elocta

Swedish Orphan Biovitrum (Sobi) has received approval from the European Medicines Agency (EMA) for the grouped type II 15 K Variation for Elocta (efmoroctocog alfa), recombinant extended half-life factor VIII Fc fusion protein product for the treatment of haemophilia A.

The variation involves several changes, including the approval of Elocta drug substance manufacturing in 15 000 litre scale bioreactors.

As a part of collaboration between Sobi and Bioverativ, Bioverativ will manufacture Elocta for Sobi.

Vice president Philip Wood said that Sobi was supplying Elocta across the territories it has arranged deals. He said the recent EMA approval is another important step toward fulfilling that commitment.

Wood, who is Commercial Therapeutic Area Head Haemophilia at Sobi, said: “This also supports our global commitment with Bioverativ to donate up to 1 billion international units of Elocta and Alprolix to the developing world. The companies have already donated more than 200 million international units, making thousands of treatments possible over the last 18 months in collaboration with the World Federation of Hemophilia.”