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
|Jun 22, 2017||New Data at EAN Show Genentech’s Ocrevus (Ocrelizumab) Significantly Reduced Multiple Measures of Disease Progression in Relapsing and Primary Progressive Multiple Sclerosis|
|Mar 28, 2017|| FDA Approves Ocrevus (ocrelizumab) for Relapsing and Primary Progressive Forms of Multiple Sclerosis|
|Dec 20, 2016||FDA Extends Review of Application for Ocrevus (ocrelizumab)|
|Sep 13, 2016||Phase III Efficacy Results of Investigational Medicine Ocrevus (Ocrelizumab) Reinforced by Exploratory Analyses in Two Forms of Multiple Sclerosis|
|Jun 28, 2016||FDA Grants Priority Review for Genentech’s Ocrevus (ocrelizumab) Biologics License Application|
|Feb 17, 2016||U.S. FDA Grants Breakthrough Therapy Designation for Roche’s Investigational Medicine Ocrelizumab in Primary Progressive Multiple Sclerosis|
|Oct 8, 2015||Genentech’s Ocrelizumab First Investigational Medicine to Show Positive Pivotal Study Results in Both Relapsing and Primary Progressive Forms of Multiple Sclerosis|
|Sep 28, 2015||Roche’s Ocrelizumab Shows Efficacy in Primary Progressive Multiple Sclerosis in Large Phase III Study|
|Oct 20, 2011||Phase II Study Showed Ocrelizumab Maintained Significant Reduction in Disease Activity for Multiple Sclerosis Patients for Almost Two Years|
|Oct 15, 2010||Phase II Study with Ocrelizumab Shows Significant Reduction in Disease Activity for Multiple Sclerosis Patients|
|Dec 11, 2009||Genentech and Biogen Idec Announce Positive Results From First Phase III Trial of Ocrelizumab in Rheumatoid Arthritis|
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