MONDAY, June 9, 2014 (HealthDay News) -- Eloctate, Antihemophilic Factor Fc Fusion 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.
Hemophilia A is an inherited bleeding disorder that affects mostly males. Caused by a defective Factor VIII gene, it affects about 1 in 5,000 males in the United States. People with the disorder are prone to serious bleeding episodes, primarily affecting the joints.
Eloctate's safety and effectiveness were evaluated in a clinical study of 164 people. No safety concerns were identified in the trial, the FDA said.
The product is produced by Biogen Idec, based in Cambridge, Mass.
The FDA has more about this approval.
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