FDA extends review of ocrelizumab

The U.S. Food and Drug Administration (FDA) has extended its review of an application for approval of ocrelizumab for the treatment of primary progressive and relapsing MS.

The extension is the result of the submission of additional data by Genentech regarding the commercial manufacturing process. According to a press release from Genentech, the extension would permit the FDA more time to review this additional data, and is not related to the clinical trial data on benefits and safety. Ocrelizumab is a monoclonal antibody that is classified as a “biologic” therapy. Biologics are generally more complex to manufacture than chemical drugs (such as pills and capsules), as they are made from human and/or animal materials rather than chemical processes.

The original FDA approval decision date of December 28, 2016 has been is extended to on or before March 28, 2017.

About ocrelizumab

Ocrelizumab is a monoclonal antibody that binds to a molecule (CD20) on the surface of immune cells called B cells, and reduces the numbers of certain B cells that are circulating in the blood. B cells have several functions including making antibodies, and they are believed to play a role in immune-system-mediated damage to brain and spinal cord tissues in MS. Ocrelizumab is administered by intravenous infusion every 6 months.

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