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Idelvion Approved for Hemophilia B

Posted 8 Mar 2016 by Drugs.com

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. ... Read more

Related support groups: Hemophilia B, Coagulation Factor Ix, Idelvion

FDA Approves Idelvion (coagulation factor IX (recombinant), albumin fusion protein) to Treat Patients with Hemophilia B

Posted 8 Mar 2016 by Drugs.com

March 4, 2016 – The U.S. Food and Drug Administration today approved Idelvion, Coagulation Factor IX (Recombinant), Albumin Fusion Protein, for use in children and adults with Hemophilia B. Idelvion is the first coagulation factor-albumin fusion protein product to be approved, and the second Factor IX fusion protein product approved in the U.S. that is modified to last longer in the blood. “The approval of Idelvion provides another important therapeutic option for children and adults with Hemophilia B to help prevent or control bleeding and reduce the frequency of bleeding episodes,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. According to the Centers for Disease Control and Prevention, Hemophilia B is a rare inherited bleeding disorder that prevents blood from clotting normally. The disorder primarily affects males and, rarely, f ... Read more

Related support groups: Hemophilia B, Coagulation Factor Ix, Idelvion

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Hemophilia B

Idelvion Patient Information at Drugs.com