Swissmedic grants approval for Sobi’s Elocta to treat haemophilia A

27 June 2016 (Last Updated June 27th, 2016 18:30)

Specialty healthcare company Swedish Orphan Biovitrum (Sobi) has received approval from the Swiss Agency for Therapeutic Products, Swissmedic, for its Elocta (rFVIIIFc) to treat patients affected with haemophilia A.

protein

Specialty healthcare company Swedish Orphan Biovitrum (Sobi) has received approval from the Swiss Agency for Therapeutic Products, Swissmedic, for its Elocta (rFVIIIFc) to treat patients affected with haemophilia A.

Haemophilia A is a rare but chronic genetic disorder, in which blood clotting in a person is impaired as a result of missing or reduced levels of a protein known as factor VIII.

Elocta (efmoroctocog alfa) is the only recombinant factor VIII Fc fusion protein that offers an extended half-life in the body.

The therapy has been approved to treat haemophilia A in Switzerland in order to provide prolonged protection to the patient against bleeding episodes, with prophylactic injections every three to five days.

Sobi Haemophilia vice-president and medical therapeutic area head Dr Krassimir Mitchev said: "The Swiss approval of Elocta is an important milestone for the country's haemophilia A community, offering the potential to improve the care of people with haemophilia A.

"Our focus is now to ensure timely and sustainable access to Elocta for people living with haemophilia A in Switzerland."

"Our focus is now to ensure timely and sustainable access to Elocta for people living with haemophilia A in Switzerland."

Elocta can be used for on-demand, as well as prophylaxis treatment of people of all ages affected with haemophilia A.

Sobi, in collaboration with American biotechnology company Biogen, is responsible for the development and marketing of Elocta for haemophilia A.

The company holds final development and commercialisation rights in the Sobi territory that comprises Europe, Russia, North Africa and most Middle Eastern markets, while Biogen develops and manufactures Elocta and has marketing rights in North America and all other worldwide regions, excluding the Sobi territory.


Image: Deficiency in coagulation factor VIII is the cause of haemophilia A. Photo: courtesy of www.pdb.org / Wikimedia Commons.