Swedish Orphan Biovitrum AB (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 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.

Elocta (efmoroctocog alfa) is a recombinant clotting factor therapy developed for haemophilia A using Fc fusion technology to prolong circulation in the body. It is engineered by fusing factor VIII to the Fc portion of immunoglobulin G subclass 1, or IgG1 (a protein commonly found in the body), enabling Elocta to use a naturally occurring pathway to extend the time the therapy remains in the body. While Fc fusion technology has been used for more than 15 years, Sobi and Bioverativ have optimised the technology and are the first companies to utilise it in the treatment of haemophilia. Elocta is manufactured using a human cell line in an environment free of animal and human additives.

Elocta is approved for the treatment of haemophilia A in the European Union, Switzerland, Iceland, Liechtenstein, Norway and Kuwait, marketed by Sobi. It is approved and marketed as ELOCTATE by Bioverativ  in the United States, Japan and Canada. It is also approved in  Australia, New Zealand, Brazil and other countries, and Bioverativ has marketing rights in these regions.

As with any factor replacement therapy, allergic-type hypersensitivity reactions and development of inhibitors may occur in the treatment of haemophilia A. Inhibitor development has been observed with Elocta, including in previously untreated patients. Note that the indication for previously untreated patients is not included in the EU Product Information for Elocta.