Swedish Orphan Biovitrum (Sobi) has begun enrolling patients for the A-SURE study, which is designed to evaluate the effectiveness of Elocta compared to conventional FVIII products in the prophylactic treatment of patients with haemophilia A.
Haemophilia is an agenetic disorder whereby the ability of a person's blood to clot is impaired.
The 24-month long A-SURE study expects to enrol 350 patients in around ten European countries.
Swedish Orphan Biovitrum medical and clinical sciences vice-president Stefan Lethagen said: “Elocta is the first extended half-life FVIII product approved by the European Commission and, as such, represents a meaningful step in the treatment of haemophilia.
“Pharmacokinetic data from the phase lll trials indicate that Elocta can achieve higher FVIII levels in plasma over a longer period of time compared to the conventional haemophilia products given at the same dose.
“The clinical data shows that effective bleed prevention can be achieved with Elocta with extended dosing intervals. A-SURE is an important study that aims to evaluate the effectiveness of Elocta in a real world-setting.”
The company has used Fc fusion technology to develop Elocta, a recombinant clotting factor VIII therapy developed for haemophilia A with prolonged circulation in the body.
In addition, Sobi has partnered with Biogen to develop and commercialise Elocta, also known as Eloctate.
However, Sobi has the final development and commercialisation rights of Elocta in Europe, North Africa, Russia and most Middle Eastern markets.