According to the National Multiple Sclerosis Society, approximately 400,000 Americans acknowledge having MS, and every week about 200 people are diagnosed. Worldwide, multiple sclerosis may affect 2.5 million individuals.
Alemtuzumab is licensed in the United States as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL), and outside of the U.S. for the treatment of B-CLL in patients who have been treated with alkylating agents and who have failed fludarabine therapy. The product was launched in its oncology indication in 2001 in the US, where it is marketed by Bayer HealthCare Pharmaceuticals Inc. as Campath(R), and in Europe, where it is named MabCampath(R).
Alemtuzumab is a humanized monoclonal antibody that binds to a specific target, CD52, on cell surfaces and directs the body's immune system to destroy those cells. It is the first and only monoclonal antibody approved by the FDA for the treatment of patients with B-CLL.
Genzyme and Bayer Schering Pharma AG, Germany are co-developing alemtuzumab in oncology, multiple sclerosis and other indications. Bayer Schering Pharma AG, Germany holds exclusive worldwide marketing and distribution rights to alemtuzumab.
Campath has a boxed warning which includes information on cytopenias,
infusion reactions, and infections. The most commonly reported adverse
reactions in patients with B-CLL were infusion reactions (fever, chills,
hypotension, urticaria, nausea, rash, tachycardia, dyspnea), cytopenias
(neutropenia, lymphopenia, thrombocytopenia, anemia), and infections (CMV
viremia, CMV infection, other infections). In clinical trials, the
frequency of infusion reactions was highest in the first week of treatment.
Other commonly reported adverse reactions include vomiting, abdominal pain,
insomnia and anxiety. The most commonly reported serious adv
|SOURCE Genzyme Corporation|
Copyright©2007 PR Newswire.
All rights reserved