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Ocrevus Approval History

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 History and FDA Approval Process for Ocrevus

DateArticle
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)
Sep 13, 2016Phase III Efficacy Results of Investigational Medicine Ocrevus (Ocrelizumab) Reinforced by Exploratory Analyses in Two Forms of Multiple Sclerosis
Jun 28, 2016FDA Grants Priority Review for Genentech’s Ocrevus (ocrelizumab) Biologics License Application
Feb 17, 2016U.S. FDA Grants Breakthrough Therapy Designation for Roche’s Investigational Medicine Ocrelizumab in Primary Progressive Multiple Sclerosis
Oct  8, 2015Genentech’s Ocrelizumab First Investigational Medicine to Show Positive Pivotal Study Results in Both Relapsing and Primary Progressive Forms of Multiple Sclerosis
Sep 28, 2015Roche’s Ocrelizumab Shows Efficacy in Primary Progressive Multiple Sclerosis in Large Phase III Study
Oct 20, 2011Phase II Study Showed Ocrelizumab Maintained Significant Reduction in Disease Activity for Multiple Sclerosis Patients for Almost Two Years
Oct 15, 2010Phase II Study with Ocrelizumab Shows Significant Reduction in Disease Activity for Multiple Sclerosis Patients
Dec 11, 2009Genentech and Biogen Idec Announce Positive Results From First Phase III Trial of Ocrelizumab in Rheumatoid Arthritis

Further information

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