MONDAY, March 31, 2014 (HealthDay News) The drug Alprolix has been approved by the U.S. Food and Drug Administration as the first long-acting hemophilia B clotting agent, the FDA said in a news release.
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The product, formally known as "coagulation factor IX recombinant Fc Fusion protein" is the first hemophilia B remedy designed to require less frequent injections than prior treatments, the FDA said. It was approved to help control and prevent bleeding episodes and to manage bleeding during surgery.
Hemophilia B is a blood-clotting disorder, primarily affecting males, caused by an abnormal Factor IX gene. Affecting some 3,300 people in the United States, it can lead to potentially deadly bleeding episodes.
Alprolix was evaluated in clinical studies involving 123 people, ages 12-71, with severe hemophilia B. No safety issues were identified during the trials, the FDA said.
The product is manufactured by Biogen Idec, located in Cambridge, Mass.
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