Rozanolixizumab
Rozanolixizumab, sold under the brand name Rystiggo, is a monoclonal antibody used for the treatment of myasthenia gravis.[1] Rozanolixizumab is a humanized and chimeric monoclonal antibody;[2] and is a neonatal Fc receptor blocker.[1][2]
Monoclonal antibody | |
---|---|
Type | Whole antibody |
Source | Chimeric/humanized hybrid |
Target | Neonatal Fc receptor (FCGRT) |
Clinical data | |
Trade names | Rystiggo |
Other names | UCB-7665, rozanolixizumab-noli |
License data | |
Routes of administration | Subcutaneous |
ATC code |
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Legal status | |
Legal status | |
Identifiers | |
CAS Number | |
DrugBank | |
UNII | |
KEGG | |
Chemical and physical data | |
Formula | C6462H9984N1704O2016S44 |
Molar mass | 145211.51 g·mol−1 |
The most common adverse reactions include headache, infections, diarrhea, pyrexia, hypersensitivity reactions, and nausea.[3]
Rozanolixizumab was approved for medical use in the United States in June 2023.[4][5]
Medical uses
Rozanolixizumab is indicated for the treatment of generalized myasthenia gravis in adults who are anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibody positive.[1][6]
Society and culture
Names
Rozanolixizumab is the international nonproprietary name.[2]
References
- "Rystiggo- rozanolixizumab injection, solution". DailyMed. 30 June 2023. Retrieved 29 August 2023.
- World Health Organization (2017). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 77". WHO Drug Information. 31 (1). hdl:10665/330984.
- "FDA Roundup: June 27, 2023". U.S. Food and Drug Administration. 27 June 2023. Retrieved 28 June 2023.
This article incorporates text from this source, which is in the public domain.
- "Novel Drug Approvals for 2023". U.S. Food and Drug Administration (FDA). 28 June 2023. Retrieved 28 June 2023.
- "UCB announces U.S. FDA approval of Rystiggo (rozanolixizumab-noli) for the treatment of adults with generalized myasthenia gravis" (Press release). UCB. 27 June 2023. Retrieved 28 June 2023 – via PR Newswire.
- https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761286Orig1s000ltr.pdf
This article incorporates text from this source, which is in the public domain.
External links
- Clinical trial number NCT03971422 for "A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis" at ClinicalTrials.gov
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