Soliris, a first-in-class terminal complement inhibitor, is approved in nearly 40 countries as a treatment for patients with aHUS and in nearly 50 countries as a treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH), a debilitating, ultra-rare and life-threatening blood disorder characterized by complement-mediated hemolysis (destruction of red blood cells). Both aHUS and PNH are caused by chronic uncontrolled complement activation.
The following abstracts will be presented in a poster session on
Abstract 783: "Eculizumab Inhibits Thrombotic Microangiopathy and Improves Renal Function in Adult Atypical Hemolytic Uremic Syndrome Patients: 1-Year Update," Fakhouri, et al.
Accessible at: http://www.abstracts2view.com/asn_2014/view.php?nu=783&type=abstract
Abstract 1667: "Characteristics of 406 Adult and Pediatric Patients in the Global aHUS Registry," Licht, et al.
Accessible at: http://www.abstracts2view.com/asn_2014/view.php?nu=1667&type=abstract
Abstract 1952: "Time to End-Stage Renal Disease in Patients With Atypical Hemolytic Uremic Syndrome Receiving Supportive Care and Eculizumab," Khursigara, et al.
Accessible at: http://www.abstracts2view.com/asn_2014/view.php?nu=1952&type=abstract
Abstract 2703: "Eculizumab Reduces Terminal Complement, Complement Alternative Pathway Activation, Inflammation, Endothelial Damage, Thrombosis and Renal Injury Markers in Patients With Atypical Hemolytic Uremic Syndrome," Cofiell, et al.
Accessible at: http://www.abstracts2view.com/asn_2014/view.php?nu=2703&type=abstract
Abstract 1915: "Safety and Efficacy of Eculizumab in Pediatric Patients With aHUS, With or Without Baseline Dialysis,"
Accessible at: http://www.abstracts2view.com/asn_2014/view.php?nu=1915&type=abstract
Abstract 2728: "Safety and Efficacy of Eculizumab in Adult aHUS Patients, With or Without a History of Renal Transplant," Loirat, et al.
Accessible at: http://www.abstracts2view.com/asn_2014/view.php?nu=2728&type=abstract
Abstract 2726: "Eculizumab Safety and Efficacy in Adult Patients With aHUS, With or Without Baseline Dialysis," Fakhouri, et al.
Accessible at: http://www.abstracts2view.com/asn_2014/view.php?nu=2726&type=abstract
About Soliris® (eculizumab)
Soliris is a first-in-class terminal complement inhibitor developed from the laboratory through regulatory approval and commercialization by Alexion. Soliris is approved in the U.S. (2007),
More information including the full U.S. prescribing information on Soliris is available at www.soliris.net.
Important Safety Information
The U.S. product label for Soliris includes a boxed warning: "Life-threatening and fatal meningococcal infections have occurred in patients treated with Soliris. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early [see Warnings and Precautions (5.1)]. Comply with the most current
In patients with PNH, the most frequently reported adverse events observed with Soliris treatment in clinical studies were headache, nasopharyngitis (runny nose), back pain and nausea. Soliris treatment of patients with PNH should not alter anticoagulant management because the effect of withdrawal of anticoagulant therapy during Soliris treatment has not been established. In patients with aHUS, the most frequently reported adverse events observed with Soliris treatment in clinical studies were headache, diarrhea, hypertension, upper respiratory infection, abdominal pain, vomiting, nasopharyngitis, anemia, cough, peripheral edema, nausea, urinary tract infections, pyrexia. Soliris is not indicated for the treatment of patients with Shiga-toxin E. coli-related hemolytic uremic syndrome (STEC-HUS). Please see full prescribing information for Soliris, including BOXED WARNING regarding risk of serious meningococcal infection.
About Alexion
Alexion is a biopharmaceutical company focused on serving patients with severe and rare disorders through the innovation, development and commercialization of life-transforming therapeutic products. Alexion is the global leader in complement inhibition and has developed and markets Soliris® (eculizumab) as a treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two debilitating, ultra-rare and life-threatening disorders caused by chronic uncontrolled complement activation. Soliris is currently approved in nearly 50 countries for the treatment of PNH and in nearly 40 countries for the treatment of aHUS. Alexion is evaluating other potential indications for Soliris in additional severe and ultra-rare disorders beyond PNH and aHUS, and is developing other highly innovative biotechnology product candidates, including asfotase alfa, across multiple therapeutic areas. This press release and further information about Alexion can be found at: www.alexionpharma.com.
[ALXN-G]
Alexion:
Media
Executive Director, Corporate Communications
or
Senior Director, Corporate Communications
or
Investors
Executive Director, Investor Relations
Source:
News Provided by Acquire Media