Swedish Orphan Biovitrum 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 Fc fusion protein product for the treatment of haemophilia A.
“Sobi is committed to providing a consistent and reliable supply of Elocta across our territories and the recent EMA approval is another important step toward fulfilling that commitment,” says Philip Wood, Vice President and Commercial Therapeutic Area Head Haemophilia at Sobi. “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.”
Bioverativ has manufacturing responsibility for Elocta to Sobi as part of a collaboration between Sobi and Bioverativ.