FDA extends review of application for Ocrevus

Extension is the result of the submission of additional data regarding the commercial manufacturing process of the biologic.

The extension is the result of the submission of additional data by Genentech regarding the commercial manufacturing process of Ocrevus, which required additional time for FDA review. The extension is not related to the product's efficacy or safety.

“We strongly believe in the potential of Ocrevus as a new therapeutic option for both people with relapsing forms of multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS),” said Sandra Horning, chief medical officer and head of Global Product Development. “We are working closely with the FDA during their review and are committed to bringing this innovative medicine to the over 400,000 people with MS in the US living with this disabling disease as quickly as possible.”

Ocrevus is an investigational, humanized monoclonal antibody designed to selectively target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage. This nerve cell damage can lead to 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.