Soliris and PNH
The following abstract will be presented in an oral session on
"Long Term Treatment with Eculizumab In Paroxysmal Nocturnal Hemoglobinuria (PNH): Sustained Efficacy and Improved Survival," Kelly, et al.
Abstract: http://ash.confex.com/ash/2010/webprogram/Paper29252.html.
The following abstract will be presented in a poster session on
"Evaluation of Paroxysmal Nocturnal Hemoglobinuria Disease Burden: The Patient's Perspective. A Report from the International PNH Registry," Muus, et al.
Abstract: http://ash.confex.com/ash/2010/webprogram/Paper33464.html.
The following abstract will be presented in a poster session on
"Use of Blood Transfusions in Paroxysmal Nocturnal Hemoglobinuria Patients with and without Aplastic Anemia Enrolled in the Global PNH Registry," Schrezenmeier, et al.
Abstract: http://ash.confex.com/ash/2010/webprogram/Paper34068.html.
The following abstracts will be presented in a poster session on
"Long Term Safety and Efficacy of Sustained Eculizumab Treatment In Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)," Brodsky, et al.
Abstract: http://ash.confex.com/ash/2010/webprogram/Paper31763.html.
"Association Between Elevated Hemolysis at Diagnosis and Early Mortality and Risk of Thrombosis In Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients with Cytopenia," Kim, et al.
Abstract: http://ash.confex.com/ash/2010/webprogram/Paper32764.html.
Samalizumab
During the meeting, researchers are also scheduled to present results from a Phase 1 study investigating samalizumab, an anti-CD200 antibody developed by Alexion, in patients with treatment refractory chronic lymphocytic leukemia or multiple myeloma.
The following abstract will be presented in a poster session on
"First-in-Human Phase I Dose Escalation Study of a Humanized Anti-CD200 Antibody (Samalizumab) in Patients with Advanced Stage B cell Chronic Lymphocytic Leukemia (B-CLL) or Multiple Myeloma (MM)," Mahadevan, et al.
Abstract: http://ash.confex.com/ash/2010/webprogram/Paper30391.html.
About Soliris
Soliris is a first-in-class terminal complement inhibitor developed from the laboratory through regulatory approval and commercialization by Alexion. Soliris has been approved in the U.S.,
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 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. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early. Vaccinate patients with a meningococcal vaccine at least two weeks prior to receiving the first dose of Soliris; revaccinate 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
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