Genentech, a member of the Roche Group, has won FDA authorization for the first treatment indicated for both relapsing plus primary progressive forms of multiple sclerosis (MS).
Ocrevus™ (ocrelizumab) is a humanized monoclonal antibody designed to selectively target CD20-positive B cells, which are thought to be a key contributor to myelin and axonal damage that can lead to disability in people along with MS. The drug requires administration by intravenous infusion every 6 months— a first dose of two 300-mg infusions given 2 weeks apart, followed by subsequent doses associated with single 600-mg infusions.
Based on preclinical studies, Genentech stated, Ocrevus is thought to work by binding to CD20 cell-surface proteins expressed on certain B cells, although not on stem cells or plasma cells, thus conserving important functions of the immune system.
Ocrevus will be available in the particular U. S. within 2 weeks, Genentech said.
“ The particular FDA’ s approval of…