Ocrelizumab, sold under the brand name Ocrevus, is a medication used for the treatment of multiple sclerosis (MS). It is a humanized anti-CD20 monoclonal antibody.[8] It targets CD20 marker on B lymphocytes and is an immunosuppressive drug.[10] Ocrelizumab binds to an epitope that overlaps with the epitope to which rituximab binds.[10]
It was approved by the US Food and Drug Administration (FDA) in March 2017,[11] and the first FDA approved drug for the primary progressive form of MS; it was discovered and developed and is marketed by Hoffmann–La Roche's subsidiary Genentech under the trade name Ocrevus.[12][8] With the approval, the FDA also required the company to conduct several Phase IV clinical trials to better understand whether the drug is safe and effective in young people, cancer risks, and effects on pregnant women and children they might bear.[13]
The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[14]
^"Ocrelizumab (Ocrevus) Use During Pregnancy". Drugs.com. 13 August 2019. Retrieved 28 March 2020.
^ ab"Ocrevus PI" (PDF). Retrieved 31 March 2024.
^"Prescription medicines: registration of new chemical entities in Australia, 2017". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 9 April 2023.
^"Prescription medicines and biologicals: TGA annual summary 2017". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 31 March 2024.
^"Regulatory Decision Summary for Ocrevus". Drug and Health Product Register. 23 October 2014.
^"Neurological therapies". Health Canada. 9 May 2018. Retrieved 13 April 2024.
^"Ocrevus 300 mg concentrate for solution for infusion - Summary of Product Characteristics (SmPC)". (emc). 30 December 2019. Retrieved 28 March 2020.
^ abc"Ocrevus- ocrelizumab injection". DailyMed. 13 December 2019. Retrieved 25 April 2020.
^Cite error: The named reference Ocrevus EPAR was invoked but never defined (see the help page).
^ abMcGinley MP, Moss BP, Cohen JA (January 2017). "Safety of monoclonal antibodies for the treatment of multiple sclerosis". Expert Opinion on Drug Safety. 16 (1): 89–100. doi:10.1080/14740338.2017.1250881. PMID 27756172. S2CID 36762194.
^"Ocrevus (ocrelizumab) Injection". U.S. Food and Drug Administration (FDA). 9 May 2017. Retrieved 25 April 2020.
^Winslow R (28 March 2017). "After 40-year odyssey, first drug for aggressive MS wins FDA approval". STAT.
^"BLA Approval Letter" (PDF). U.S. Food and Drug Administration (FDA). 28 March 2017.
^New Drug Therapy Approvals 2017 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2018. Retrieved 16 September 2020.
Ocrelizumab, sold under the brand name Ocrevus, is a medication used for the treatment of multiple sclerosis (MS). It is a humanized anti-CD20 monoclonal...
continue to emerge in modern medicine. In March 2017, the FDA approved ocrelizumab as a treatment for primary progressive MS in adults, the first drug to...
deficiency, later discontinued in 2004 and replaced by Nutropin AQ. Ocrevus (ocrelizumab), for MS. Peginterferon/alfa-2a|Pegasys]], (peginterferon alfa-2a) for...
monoclonal treatment, in managing this disease, other anti-CD20 drugs such as ocrelizumab, veltuzumab, and ofatumumab have been explored as potential treatments...
antigen. CD20 is the target of the monoclonal antibodies rituximab, ocrelizumab, obinutuzumab, ofatumumab, ibritumomab tiuxetan, tositumomab, and ublituximab...
cancer indication due to promising phase II results. 2017: Ocrevus (ocrelizumab): The first FDA-approved therapy that treats both relapsing-remitting...
has led to some other anti-CD20 monoclonal antibodies being developed: ocrelizumab, humanized (90%-95% human) B cell-depleting agent. ofatumumab (HuMax-CD20)...
anti-CD20 monoclonal antibody, has been approved for some indications. Ocrelizumab, ofatumumab, and "third-generation" anti-CD20 monoclonals are in development...
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CSF Biomarkers in Primary Progressive MS and Relapsing MS in the OBOE (Ocrelizumab Biomarker Outcome Evaluation) Trial (1635). Amit Bar-Or, Jeffrey Bennett...
treatment for diseases such as multiple sclerosis and optic neuritis. Ocrelizumab "Biogen MS Drug Results Are 'Mildly Encouraging' In Eye Disease Test"...
remissions. There is currently only one approved medication for PPMS—Ocrevus (Ocrelizumab). In 2006, DaSilva decided to document his challenges as a filmmaker...
Alemtuzumab, daclizumab and CD20 monoclonal antibodies such as rituximab, ocrelizumab and ofatumumab have all shown some benefit and are under study as potential...
monoclonal antibodies: Alemtuzumab (Lemtrada, Campath). Natalizumab (Tysabri) Ocrelizumab (Ocrevus) which is also approved for primary progressive (PPMS) Ofatumumab...
the α-subunit of IL-2 receptor on the surface of mature lymphocytes), ocrelizumab (against CD20 marker on B-cells). However, the frequent adverse effects...
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