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Coagulation Factor Ix News

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

Emergent BioSolutions Announces FDA Approval of Ixinity [coagulation factor IX (recombinant)] for Hemophilia B

Posted 1 May 2015 by Drugs.com

GAITHERSBURG, Md., April 30, 2015 (GLOBE NEWSWIRE) – Emergent BioSolutions Inc. (NYSE:EBS) today announced that the U.S. Food and Drug Administration (FDA) has approved Ixinity [coagulation factor IX (recombinant)], an intravenous recombinant human coagulation factor IX therapeutic for the control and prevention of bleeding episodes and for perioperative management in adults and children, ≥12 years of age, with Hemophilia B. Hemophilia B is a bleeding disorder caused by a mutation on the factor IX gene resulting in a deficiency of clotting factor IX in the blood, which controls bleeding. "Emergent is committed to making a positive impact on the Hemophilia B community, including people living with this chronic bleeding disorder as well as their families, caregivers, and healthcare providers," said Barry Labinger, Executive Vice President and President, Biosciences Division at Emergent B ... Read more

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

Long-Acting Clotting Agent Alprolix Approved for Form of Hemophilia

Posted 31 Mar 2014 by Drugs.com

MONDAY, March 31, 2014 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. 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 ... Read more

Related support groups: Hemophilia B, Rixubis, BeneFix, Mononine, Alphanine SD, BeneFIX 250 Int'l Units, Coagulation Factor Ix

FDA Approves Rixubis - First Recombinant Coagulation Factor IX For Use in Preventing Bleeding Episodes

Posted 27 Jun 2013 by Drugs.com

June 27, 2013 – The U.S. Food and Drug Administration yesterday approved Rixubis [Coagulation Factor IX (Recombinant)] for use in people with hemophilia B who are 16 years of age and older. Rixubis is indicated for the control and prevention of bleeding episodes, perioperative (period extending from the time of hospitalization for surgery to the time of discharge) management, and routine use to prevent or reduce the frequency of bleeding episodes (prophylaxis). An inherited blood clotting disorder mainly affecting males, Hemophilia B is caused by mutations in the Factor IX gene and leads to deficiency of Factor IX. Hemophilia B affects about 3,300 people in the United States. Individuals with Hemophilia B can experience potentially serious bleeding, mainly into the joints, which can be destroyed by such bleeding. “As the first recombinant coagulation factor IX indicated s ... Read more

Related support groups: Hemophilia B, Hemophilia, Coagulation Defects and Disorders, Coagulation Factor Ix

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Further Information

Related Condition Support Groups

Hemophilia B, Factor IX Deficiency

Related Drug Support Groups

BeneFix, Rixubis, Idelvion, Alprolix, Ixinity, Mononine, BeneFIX 250 Int'l Units, Alphanine SD

Coagulation Factor Ix Patient Information at Drugs.com