Biogen, Sobi present new data from Phase III study of Eloctate for hemophilia A

A clotting factor, Eloctate is under development using Biogen Idec’s novel and proprietary monomeric Fc fusion technology.

Announced at the XXIV International Society on Thrombosis and Haemostasis (ISTH) Congress in Netherlands, the data emphasizes the probability of new FVIII candidate’s to minimize the number of intravenous injections to treat hemophilia A.

Additionally, the data highlights its efficacy in controlling bleeding during and after surgery, and efficacy in treating acute bleeding episodes.

Biogen hemophilia therapeutic area chief medical officer and Global Medical Affairs senior vice president Dr Glenn Pierce said, "The A-LONG data presented at ISTH support the potential of ELOCTATE to enable longer intervals between prophylactic (preventative) injections compared to the current standard of care."

An assessment to treat acute bleeding episodes across the prophylaxis and episodic (on demand) treatment arms of the phase 3 A-LONG study demonstrated that over 87% of bleeds were controlled with a single injection of Eloctate and over 97% of bleeds were controlled with two or fewer injections.

Sobi chief medical officer and development senior vice president Birgitte Volck said that these new data from the A-LONG study show potential for the application of Fc fusion technology in hemophilia.

The FDA is currently reviewing ELOCTATE’s biologics license application (BLA) for the treatment of hemophilia A, while a marketing application for the same has been submitted in Australia with additional regulatory filings being planned.