The FDA has approved Eloctate (coagulation factor VIII [recombinant], Fc fusion protein; Biogen Idec) for use in adults and children with hemophilia A.

Eloctate is approved to help control and prevent bleeding episodes, in perioperative management, and in routine prophylaxis to prevent or reduce the frequency of bleeding episodes. This is the first hemophilia A treatment that requires fewer injections in the prevention or reduction of bleeding frequency.

RELATED: Eloctate Shows Efficacy in Hemophilia A Trial

The safety and efficacy of Eloctate were evaluated in A-LONG, a Phase 3 clinical trial of 164 patients that compared the prophylactic treatment regimen to on-demand therapy. The study showed that Eloctate was effective in treating bleeding episodes, in preventing or reducing bleeding, and in the control of bleeding during and after surgical procedures.

Eloctate will be available in 250 IU, 500 IU, 750 IU, 1000 IU, 1500 IU, 2000 IU, and 3000 IU strength vials with supplies. Eloctate is expected to be available in July 2014.

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