Satralizumab

Satralizumab
Monoclonal antibody
TypeWhole antibody
SourceHumanized (from mouse)
Targetinterleukin 6 receptor
Clinical data
Trade namesEnspryng
Other namesSA-237, sapelizumab, satralizumab-mwge
AHFS/Drugs.comMonograph
License data
Pregnancy
category
Routes of
administration		Subcutaneous
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
UNII
KEGG
Chemical and physical data
FormulaC6340H9776N1684O2022S46
Molar mass143416.47 g·mol−1

Satralizumab, sold under the brand name Enspryng, is a humanized monoclonal antibody medication that is used for the treatment of neuromyelitis optica spectrum disorder (NMOSD), a rare autoimmune disease.[6][8] The drug is being developed by Chugai Pharmaceutical, a subsidiary of Roche.[9]

The most common side effects include the common cold (nasopharyngitis), headache, upper respiratory tract infection, inflammation of the lining of the stomach, rash, joint pain, extremity pain, fatigue and nausea.[6]

Satralizumab regulates inflammation by inhibiting the interleukin-6 (IL-6) receptor, a key mediator of the immune response.[10]

Satralizumab was approved for medical use in the United States in August 2020,[11] and in the European Union in June 2021.[7][12] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[13]

  1. ^ a b "AusPAR: Satralizumab". Therapeutic Goods Administration (TGA). 23 August 2021. Retrieved 4 September 2021.
  2. ^ a b "Enspryng". Therapeutic Goods Administration (TGA). 26 November 2020. Retrieved 10 September 2021.
  3. ^ "Satralizumab Product information". Drug Product Database. Health Canada. 25 April 2012. Retrieved 17 August 2020.
  4. ^ "Summary Basis of Decision (SBD) for Enspryng". Health Canada. 23 October 2014. Retrieved 29 May 2022.
  5. ^ Cite error: The named reference Enspryng FDA label was invoked but never defined (see the help page).
  6. ^ a b c Cite error: The named reference FDA PR was invoked but never defined (see the help page).
  7. ^ a b "Enspryng EPAR". European Medicines Agency. 20 April 2021. Retrieved 4 March 2023.
  8. ^ Heo YA (September 2020). "Satralizumab: First Approval". Drugs. 80 (14): 1477–1482. doi:10.1007/s40265-020-01380-2. PMC 7522096. PMID 32797372.
  9. ^ "Chugai Presents Results from Phase III Study of Satralizumab in NMOSD at ECTRIMS 2018". 15 October 2018.
  10. ^ Rosso M, Saxena S, Chitnis T (May 2020). "Targeting IL-6 receptor in the treatment of neuromyelitis optica spectrum: a review of emerging treatment options". Expert Review of Neurotherapeutics. 20 (5). Informa UK Limited: 509–516. doi:10.1080/14737175.2020.1757434. PMID 32306778. S2CID 216029479.
  11. ^ Cite error: The named reference Drug Approval Package: Enspryng was invoked but never defined (see the help page).
  12. ^ "Enspryng Product information". Union Register of medicinal products. Retrieved 3 March 2023.
  13. ^ "New Drug Therapy Approvals 2020". U.S. Food and Drug Administration (FDA). 31 December 2020. Retrieved 17 January 2021.