MONDAY, June 9, 2014 (HealthDay News) -- Eloctate, Antihemophilic Factor, Fc Fusion protein, has been approved by the U.S. Food and Drug Administration for people with Hemophilia A. It's designed to require less frequent injections than standard therapies used to reduce the frequency of bleeding episodes in people with the disorder, the FDA said in a news release.
Eloctate's safety and effectiveness were evaluated in a clinical study of 164 people. The researchers found that Eloctate was effective for the treatment of bleeding episodes, for reducing or preventing bleeding, and for the control of bleeding during and after surgery. No safety concerns were identified in the trial, the FDA said.
"The approval of this product provides an additional therapeutic option for use in the care of patients with Hemophilia A," Karen Midthun, M.D., director of the FDA's Center for Biologics Evaluation and Research, said in a statement.
The product is produced by Biogen Idec, based in Cambridge, Mass.
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