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C1 Inhibitor (Human) News
Posted 18 Jul 2014 by Drugs.com
July 17, 2014 – The U.S. Food and Drug Administration yesterday approved Ruconest, the first recombinant C1-Esterase Inhibitor product for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE). Hereditary angioedema, which is caused by having insufficient amounts of a plasma protein called C1-esterase inhibitor, affects approximately 6,000 to 10,000 people in the United States. People with HAE can develop rapid swelling of the hands, feet, limbs, face, intestinal tract, or airway. These acute attacks of swelling can occur spontaneously, or can be triggered by stress, surgery or infection. Swelling of the airway is potentially fatal without immediate treatment. “Hereditary angioedema is a rare and potentially life-threatening disease,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “Today’s approv ... Read more
CSL Behring Receives FDA Approval of Expanded Label on Berinert for Self-administration and Treatment of Acute Laryngeal Attacks of Hereditary Angioedema
Posted 4 Jan 2012 by Drugs.com
Patients with rare, sometimes life-threatening condition can now treat themselves at home at the first sign of acute facial, abdominal or laryngeal swelling attacks KING OF PRUSSIA, Pa., Jan. 3, 2012 /PRNewswire/ – CSL Behring today announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion for self-administration of Berinert ®, C1 Esterase Inhibitor (Human), a pasteurized, nanofiltered therapy indicated for the treatment of acute attacks of hereditary angioedema (HAE), a rare and potentially fatal genetic disorder. With appropriate training from a physician, patients can now self-administer Berinert by intravenous infusion. As part of the label expansion, Berinert is now also indicated to treat life-threatening laryngeal HAE attacks, as well as facial and abdominal attacks. "Once the early signs of an HAE attack begin to emerge, any delay in starting t ... Read more