Manufacturer of Natalizumab

Natalizumab, jointly developed by Biogen Idec, Cambridge, Massachusetts, and Elan Pharmaceuticals, Dublin, Ireland, is the first monoclonal antibody approved by the U.S. Food and Drug Administration (FDA) for the treatment of multiple sclerosisMS. Based on the AFFIRM and SENTINEL phase clinical trials, natalizumab was approved by the FDA for the treatment of relapsing-remitting MS in 2004, and its indications were subsequently expanded to include Crohn's disease. Natalizumab was withdrawn from the market in 2005 after cases of PML emerged, but the FDA reintroduced the drug in 2008 through a mandatory surveillance program. Natalizumab is effective in reducing the number of relapses and worsening disability in multiple sclerosis (MS) as measured by the Expanded Disability Status Scale.