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Ocrelizumab

Not to be confused with eculizumab.

Ocrelizumab
Monoclonal antibody
TypeWhole antibody
SourceHumanized (from mouse)
TargetCD20
Clinical data
Trade namesOcrevus
AHFS/Drugs.comMonograph
MedlinePlusa617026
License data
Pregnancy
category
Routes of
administration		Intravenous infusion
subcutaneous injection
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
Chemical and physical data
FormulaC6494H9978N1718O2014S46
Molar mass145818.03 g·mol−1
 ☒NcheckY (what is this?)  (verify)

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]

  1. ^ "Ocrelizumab (Ocrevus) Use During Pregnancy". Drugs.com. 13 August 2019. Retrieved 28 March 2020.
  2. ^ a b "Ocrevus PI" (PDF). Retrieved 31 March 2024.
  3. ^ "Prescription medicines: registration of new chemical entities in Australia, 2017". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 9 April 2023.
  4. ^ "Prescription medicines and biologicals: TGA annual summary 2017". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 31 March 2024.
  5. ^ "Regulatory Decision Summary for Ocrevus". Drug and Health Product Register. 23 October 2014.
  6. ^ "Neurological therapies". Health Canada. 9 May 2018. Retrieved 13 April 2024.
  7. ^ "Ocrevus 300 mg concentrate for solution for infusion - Summary of Product Characteristics (SmPC)". (emc). 30 December 2019. Retrieved 28 March 2020.
  8. ^ a b c "Ocrevus- ocrelizumab injection". DailyMed. 13 December 2019. Retrieved 25 April 2020.
  9. ^ Cite error: The named reference Ocrevus EPAR was invoked but never defined (see the help page).
  10. ^ a b McGinley 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.
  11. ^ "Ocrevus (ocrelizumab) Injection". U.S. Food and Drug Administration (FDA). 9 May 2017. Retrieved 25 April 2020.
  12. ^ Winslow R (28 March 2017). "After 40-year odyssey, first drug for aggressive MS wins FDA approval". STAT.
  13. ^ "BLA Approval Letter" (PDF). U.S. Food and Drug Administration (FDA). 28 March 2017.
  14. ^ New Drug Therapy Approvals 2017 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2018. Retrieved 16 September 2020.

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