From the FDA:
FOR IMMEDIATE RELEASE
November 23, 2004
Full press release
Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA
First Monoclonal Antibody Treatment For Multiple Sclerosis Approved
FDA today licensed a new biologic approach to treat patients with relapsing forms of multiple sclerosis (MS) to reduce the frequency of symptom flare-ups or exacerbations of the disease. MS is a chronic, often disabling disease of the brain and spinal cord.
Natalizumab, the new product, is a monoclonal antibody bioengineered from part of a mouse antibody to closely resemble a human antibody. It is being marketed under the tradename Tysabri. The product is given intravenously once a month in a physician's office.
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