FDA Clears First Long-Acting Hemophilia A Drug (Eloctate)

Megan Brooks

Disclosures

June 09, 2014

The US Food and Drug Administration (FDA) has approved Eloctate (Biogen Idec), the first long-lasting antihemophilic factor (recombinant) Fc fusion protein for use in adults and children with hemophilia A.

Eloctate is approved to help control and prevent bleeding episodes, manage bleeding during surgical procedures, and prevent or reduce the frequency of bleeding episodes.

Eloctate fuses coagulation factor VIII to the Fc protein fragment, which prolongs circulation in the body. "The therapy offers people with hemophilia A the potential to extend the interval between prophylactic infusions," the company notes.

Eloctate prophylactic infusions are started at every 4 days, which can be adjusted based on clinical response to every 3 to 5 days, the company says.

"The approval of this product provides an additional therapeutic option for use in the care of patients with Hemophilia A," Karen Midthun, MD, director of the FDA's Center for Biologics Evaluation and Research, in an FDA statement issued June 6 announcing the approval.

The safety and efficacy of Eloctate were demonstrated in a clinical trial of 164 patients that compared the prophylactic treatment regimen to on-demand therapy. "The trial demonstrated that Eloctate was effective in the treatment of bleeding episodes, in preventing or reducing bleeding and in the control of bleeding during and after surgical procedures. No safety concerns were identified in the trial," the FDA said. Common adverse reactions (incidence of greater than or equal to 1%) from the trial were arthralgia and malaise.

Hemophilia A affects 1 in every 5000 males born in the United States.

Eloctate received orphan-drug status for hemophilia A because it is intended for treatment of a rare disease. Complete prescribing information is available at www.eloctate.com.

The FDA approved Biogen's hemophilia B therapy, coagulation factor IX (recombinant) Fc fusion protein (Alprolix), in March, as reported by Medscape Medical News .

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