FDA Extends Review of Roche MS Drug

FDA has extended by three months the user fee review date for a Roche BLA for Ocrevus (ocrelizumab), indicated for treating patients with relapsing forms of multiple sclerosis (MS) and primary progressive multiple sclerosis. The new target date (3/28) will allow the agency to review a Roche submission on its commercial manufacturing process.

Roche says Ocrevus is an investigational, humanized monoclonal antibody designed to selectively target CD20-positive B cells, which are a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage that can result in disability in people with MS. “Based on preclinical studies, Ocrevus binds to CD20 cell surface proteins expressed on certain B cells, but not on stem cells or plasma cells, and therefore important functions of the immune system may be preserved,” it says.