ALEXION'S SOLIRIS PREVENTS REJECTION IN KIDNEY TRANSPLANTS.Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN), Cheshire, Conn., has announced that researchers presented early clinical and laboratory data on the potential role of terminal complement inhibition with Soliris(r) (eculizumab) for the treatment of a subset of kidney transplant patients who are at high risk for antibody-mediated rejection (AMR) of their grafts. These data were included in three oral sessions and one poster presentation at the American Transplant Congress held in Boston. This research includes interim results from an investigator-initiated study of Soliris(r) for the prevention of AMR in this subpopulation of kidney transplant patients. Abstracts listed below can be accessed at: http://www.abstracts2view.com/atc/sessionindex.php. * "Prevention of Acute Humoral hu·mor·al adj. 1. Relating to body fluids, especially serum. 2. Relating to or arising from any of the bodily humors. Humoral Pertaining to or derived from a body fluid. Rejection with C5 Inhibition," * "Prevention of Endothelial Activation with C5 Inhibition in Positive-Crossmatch Kidney Transplants" * "Anti-C5 mAb Plus Low Dose CTLA4 Ig Inhibit Alloreactive T Cells and Prolong Heart Graft Survival in Mice," * "Complement C5 Inhibitor - Is It Useful in Antibody-Mediated Rejection?" About Soliris Soliris has been approved by the U.S. Food and Drug Administration (March 2007), the European Commission (June 2007), Health Canada (January 2009) and Australia's Therapeutic Goods Administration The Therapeutic Goods Administration or TGA is the regulatory body for therapeutic goods (including medicines, medical devices, gene technology, and blood products) in Australia. (February 2009) as the first treatment for all patients with paroxysmal nocturnal hemoglobinuria paroxysmal nocturnal hemoglobinuria n. An infrequent disorder the onset of which usually occurs in the third or fourth decades of life and is characterized by periods of hemolytic anemia, hemoglobinuria primarily at night, pallor, bronzing of the skin, (PNH PNH paroxysmal nocturnal hemoglobinuria. Paroxysmal nocturnal hemoglobinuria (PNH) A rare complement disorder characterized by episodes of red blood cell destruction (hemolysis) and blood in the urine (hemoglobinuria) that is worse at ), a rare, debilitating de·bil·i·tat·ing adj. Causing a loss of strength or energy. Debilitating Weakening, or reducing the strength of. Mentioned in: Stress Reduction and life-threatening blood disorder defined by hemolysis hemolysis (hĭmŏl`ĭsĭs), destruction of red blood cells in the bloodstream. Although new red blood cells, or erythrocytes, are continuously created and old ones destroyed, an excessive rate of destruction sometimes occurs. , or the destruction of red blood cells Red blood cells Cells that carry hemoglobin (the molecule that transports oxygen) and help remove wastes from tissues throughout the body. Mentioned in: Bone Marrow Transplantation red blood cells . All four jurisdictions reviewed and approved their respective marketing applications for Soliris under their priority review or accelerated assessment procedures, and all four have designated Soliris as an orphan drug. Soliris is not approved for the treatment of transplant rejection. For more information, visit http://www.soliris.net. Important Safety Information Soliris is generally well tolerated. The most frequent adverse events observed in clinical studies were headache, nasopharyngitis (a runny nose), back pain and nausea. Treatment with Soliris should not alter anticoagulant anticoagulant (ăn'tēkōăg`yələnt), any of several substances that inhibit blood clot formation (see blood clotting). management because the effect of withdrawal of anticoagulant therapy during Soliris treatment has not been established. The U.S. product label for Soliris also includes a boxed warning: "Soliris increases the risk of meningococcal infections. Vaccinate vac·ci·nate v. To inoculate with a vaccine in order to produce immunity to an infectious disease such as diphtheria or typhus. vac patients with a meningococcal vaccine at least two weeks prior to receiving the first dose of Soliris; revaccinate Re`vac´ci`nate v. t. 1. To vaccinate a second time or again. according to current medical guidelines for vaccine use. Monitor patients for early signs of meningococcal infections, evaluate immediately if infection is suspected, and treat with antibiotics if necessary." During clinical studies, two out of 196 vaccinated PNH patients treated with Soliris experienced a serious meningococcal infection. Prior to beginning Soliris therapy, all patients and their prescribing physicians are encouraged to enroll in the PNH Registry, which is part of a special risk-management program that involves initial and continuing education and long-term monitoring for detection of new safety findings. About Alexion Alexion Pharmaceuticals, Inc. is a biopharmaceutical company working to develop and deliver lifechanging drug therapies for patients with serious and life-threatening medical conditions. Alexion is engaged in the discovery, development and commercialization of therapeutic products aimed at treating patients with a wide array of severe disease states, including hematologic hematological, hematologic pertaining to or emanating from blood cells. hematological tests total and differential white cell counts, hematocrit estimation, erythrocyte count. and kidney diseases, transplant, cancer, and autoimmune disorders. Soliris is Alexion's first marketed product, approved in the U.S. and Europe in 2007, and Canada and Australia in 2009. Alexion is evaluating other potential indications for Soliris as well as other formulations of eculizumab for additional clinical indications, and is pursuing development of other antibody product candidates in early stages of development. For more information, visit http://www.alexionpharma.com or call 203/271-8210. |
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