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Ocrevus FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 28, 2021.

FDA Approved: Yes (First approved March 28, 2017)
Brand name: Ocrevus
Generic name: ocrelizumab
Dosage form: Injection
Company: Genentech, Inc.
Treatment for: Multiple Sclerosis

Ocrevus (ocrelizumab) is a 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 and axonal nerve cell damage. Ocrevus is indicated as a treatment for both relapsing (RMS) and primary progressive (PPMS) forms of multiple sclerosis.

Development timeline for Ocrevus

Dec 14, 2020Approval FDA Approves Genentech’s Ocrevus (ocrelizumab) Shorter 2-Hour Infusion for Relapsing and Primary Progressive Multiple Sclerosis
Jun 22, 2017New Data at EAN Show Genentech’s Ocrevus (Ocrelizumab) Significantly Reduced Multiple Measures of Disease Progression in Relapsing and Primary Progressive Multiple Sclerosis
Mar 28, 2017Approval FDA Approves Ocrevus (ocrelizumab) for Relapsing and Primary Progressive Forms of Multiple Sclerosis
Dec 20, 2016FDA Extends Review of Application for Ocrevus (ocrelizumab)
Jun 28, 2016FDA Grants Priority Review for Genentech’s Ocrevus (ocrelizumab) Biologics License Application

Further information

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