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01-06-2017 | AdisInsight Report

Ocrelizumab: First Global Approval

Author: James E. Frampton

Published in: Drugs | Issue 9/2017

Abstract

Ocrelizumab (Ocrevus™) is a humanised anti-CD20 monoclonal antibody that has been developed by Genentech, Inc. (a subsidiary of Roche) for the treatment of multiple sclerosis (MS). The drug is designed to deplete B cells, which play an important role in the pathogenesis of MS. In March 2017, ocrelizumab was approved in the USA for the treatment of patients with relapsing or primary progressive forms of MS; currently, it is awaiting approval in the EU for the same indications. This article summarizes the milestones in the development of ocrelizumab leading to its first global approval for the treatment of MS.

Sorensen PS, Blinkenberg M. The potential role for ocrelizumab in the treatment of multiple sclerosis: current evidence and future prospects. Ther Adv Neurol Disord. 2016;9(1):44–52.CrossRefPubMedPubMedCentral

Genentech, Inc. OCREVUS^TM (ocrelizumab): US prescribing information. 2017. https://www.accessdata.fda.gov. Accessed 31 Mar 2017.

Genentech I. FDA approves Genentech’s OCREVUS™ (Ocrelizumab) for relapsing and primary progressive forms of multiple sclerosis [media release]. 28 Mar 2017. http://www.gene.com.

Roche, Biogen Idec. Roche and Biogen Idec announce their decision to discontinue the ocrelizumab clinical development programme in patients with rheumatoid arthritis [media release]. 19 May 2010. http://www.roche.com.

Emery P, Rigby W, Tak PP, et al. Safety with ocrelizumab in rheumatoid arthritis: results from the ocrelizumab phase III program. PLoS One. 2014;9(2):e87379

Mysler EF, Spindler AJ, Guzman R, et al. Efficacy and safety of ocrelizumab in active proliferative lupus nephritis: results from a randomized, double-blind, phase III study. Arthritis Rheum. 2013;65(9):2368–79.

Genentech Inc. IDEC Pharmaceuticals Corporation. Genentech and IDEC announce humanized anti-CD20 antibody development collaboration [media release]. 20 June 2003. http://www.gene.com.

Biogen Idec, Genentech Inc. Biogen Idec and Genentech announce restructuring of anti-CD20 collaboration agreement [media release]. 22 Oct 2010. http://www.gene.com.

Morschhauser F, Marlton P, Vitolo U, et al. Results of a phase I/II study of ocrelizumab, a fully humanized anti-CD20 mAb, in patients with relapsed/refractory follicular lymphoma. Ann Oncol. 2010;21(9):1870–6.CrossRefPubMed

10.

Hauser SL, Bar-Or A, Comi G, et al. Ocrelizumab versus interferon beta-1a in relapsing multiple sclerosis. N Engl J Med. 2017;376(3):221–34.CrossRefPubMed

11.

Kappos L, Li D, Calabresi PA, et al. Long-term safety and efficacy of ocrelizumab in patients with relapsing-remitting multiple sclerosis: week 144 results of a phase II, randomised, multicentre trial [abstract no. P362 and poster]. 28th Congress of the European Committee for Treatment and Research in Multiple Sclerosis, Lyon; Oct 11 2012.

12.

US National Institutes of Health. ClinicalTrials.gov identifier NCT02545868. 2016. https://clinicaltrials.gov. Accessed 17 Apr 2017.

13.

Montalban X, Hauser SL, Kappos L, et al. Ocrelizumab versus placebo in primary progressive multiple sclerosis. N Engl J Med. 2017;376(3):209–20.CrossRefPubMed

14.

Kuhelj R, Deol-Bhullar G, Garas M, et al. Open-label phase III extension studies to evaluate the long-term safety and efficacy of ocrelizumab in relapsing MS and primary progressive MS [abstract no. P11192]. Eur J Neurol. 2015;23(Suppl 2):200.

15.

Hauser S, Comi G, Hartung HP, et al. Baseline demographics and disease characteristics from OPERA I and II, two phase III trials evaluating ocrelizumab in patients with relapsing multiple sclerosis [abstract no. F3139]. Eur J Neurol. 2015;22(Suppl 1):752.

16.

Kappos L, Li D, Calabresi PA, et al. Ocrelizumab in relapsing-remitting multiple sclerosis: a phase 2, randomised, placebo-controlled, multicentre trial. Lancet. 2011;378(9805):1779–87.CrossRefPubMed

17.

Genentech Inc. Phase II study showed ocrelizumab maintained significant reduction in disease activity for multiple sclerosis patients for almost two years [media release]. 20 Oct 2011. http://www.gene.com.

18.

Montalban X, Hemmer B, Rammohan K, et al. Baseline demographics and disease characteristics from ORATORIO, a phase III trial evaluating ocrelizumab in patients with primary progressive multiple sclerosis [abstract F3049]. Eur J Neurol. 2015;22(Suppl 1):706.

19.

Hartung HP, Arnold DL, Bar-Or A, et al. Infections and serious infections with ocrelizumab in relapsing multiple sclerosis and primary progressive multiple sclerosis [abstract no. P1248]. Mult Scler. 2016;22(Suppl 3):658–9.

20.

De Seze J, Arnold DL, Bar-Or A, et al. Infusion-related reactions with ocrelizumab in relapsing multiple sclerosis and primary progressive multiple sclerosis [abstract no. P720]. Mult Scler. 2016;22(Suppl 3):351–2.

Title: Ocrelizumab: First Global Approval
Author: James E. Frampton
Publication date: 01-06-2017
Publisher: Springer International Publishing
Published in: Drugs / Issue 9/2017
Print ISSN: 0012-6667
Electronic ISSN: 1179-1950
DOI: https://doi.org/10.1007/s40265-017-0757-6

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Ocrelizumab: First Global Approval

Abstract

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

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