Biogen Idec and Swedish Orphan Biovitrum (Sobi) have unveiled late-stage clinical data that seem to support the clinical and safety profile of their long-lasting recombinant factor VIII candidate Eloctate, which is currently under review for haemophilia A.
According to the firms, data presented recently at the International Society on Thrombosis and Haemostasis Congress in Amsterdam, The Netherlands, highlight the drug's potential to cut the number of intravenous injections hemophilia A patients need, as well as demonstrate its efficacy in controlling bleeding during and after surgery and in treating acute bleeding episodes.
One evaluation of the treatment of acute bleeding episodes in the Phase III A-LONG study showed that the majority - more than 87% - of bleeds were controlled with a single injection of Eloctate, and more than 97% of were controlled with two or fewer injections.
Also, findings from an analysis of the drug's performance when evaluated using two investigational haemostasis assays, revealed for the first time, show that, despite inherent patient-to-patient differences in thrombin generation activity, Eloctate and Advate were equivalent in thrombin generation potential after their infusion.
Moreover, Eloctate also showed prolonged thrombin generation activity relative to Advate, the firm said.
Data from another analysis of the A-LONG study also showed that Eloctate "consistently controlled bleeding during and after nine major surgeries in nine patients with haemophilia A", the firms said, with physicians reporting high efficacy levels of the drug during surgery, with the stoppage of bleeding rated as "excellent" for 8/9 surgeries and "good" for 1/9 surgeries.
Crucially, according to the investigators' analysis, the data were comparable to that for similar surgeries in people without the bleeding disorder.
Eloctate is currently under review in both the US and Australia, and, if approved, would be the first major treatment advance for people haemophilia A in more than two decades, Biogen noted.