Satralizumab
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized (from mouse) |
| Target | interleukin 6 receptor |
| Clinical data | |
| Trade names | Enspryng |
| Other names | SA-237, sapelizumab, satralizumab-mwge |
| AHFS/Drugs.com | Monograph |
| License data |
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| Pregnancy category | |
| Routes of administration | Subcutaneous |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C6340H9776N1684O2022S46 |
| Molar mass | 143416.47 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]
- ^ a b "AusPAR: Satralizumab". Therapeutic Goods Administration (TGA). 23 August 2021. Retrieved 4 September 2021.
- ^ a b "Enspryng". Therapeutic Goods Administration (TGA). 26 November 2020. Retrieved 10 September 2021.
- ^ "Satralizumab Product information". Drug Product Database. Health Canada. 25 April 2012. Retrieved 17 August 2020.
- ^ "Summary Basis of Decision (SBD) for Enspryng". Health Canada. 23 October 2014. Retrieved 29 May 2022.
- ^ Cite error: The named reference
Enspryng FDA labelwas invoked but never defined (see the help page). - ^ a b c Cite error: The named reference
FDA PRwas invoked but never defined (see the help page). - ^ a b "Enspryng EPAR". European Medicines Agency. 20 April 2021. Retrieved 4 March 2023.
- ^ Heo YA (September 2020). "Satralizumab: First Approval". Drugs. 80 (14): 1477–1482. doi:10.1007/s40265-020-01380-2. PMC 7522096. PMID 32797372.
- ^ "Chugai Presents Results from Phase III Study of Satralizumab in NMOSD at ECTRIMS 2018". 15 October 2018.
- ^ 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.
- ^ Cite error: The named reference
Drug Approval Package: Enspryngwas invoked but never defined (see the help page). - ^ "Enspryng Product information". Union Register of medicinal products. Retrieved 3 March 2023.
- ^ "New Drug Therapy Approvals 2020". U.S. Food and Drug Administration (FDA). 31 December 2020. Archived from the original on January 18, 2021. Retrieved 17 January 2021.