MONDAY, March 7, 2016 -- Idelvion has been approved by the U.S. Food and Drug Administration to replace a deficient blood clotting factor among people with hemophilia B.
The product -- which has the generic name of "coagulation Factor IX, albumin fusion protein" -- is created using recombinant DNA technology that links the blood clotting protein known as Factor IX to another blood protein, albumin. This technology allows the protein to last longer when given intravenously, the FDA said in a news release.
People with the rare genetic disorder hemophilia B are prone to recurring episodes of serious bleeding, primarily into the joints. Most people with the disorder are male, although it occasionally affects females, the agency said.
The new product is meant to control bleeding episodes and to reduce their frequency. It can also be given to prevent bleeding after surgery, the FDA said.
Idelvion was evaluated in clinical studies involving 90 adults and children, ages 1 year to 61. No safety concerns were identified during the studies, and the most common side effect was headache, the agency said.
The product is manufactured by CSL Behring, based in King of Prussia, Penn.
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