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 |
AHFS/Drugs.com | Monograph |
MedlinePlus | a623040 |
License data | |
Routes of administration | Subcutaneous |
ATC code | |
Legal status | |
Legal status | |
Identifiers | |
CAS Number | |
DrugBank | |
UNII | |
KEGG | |
Chemical and physical data | |
Formula | C6462H9984N1704O2016S44 |
Molar mass | 145211.51 g·mol−1 |
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;[4] and is a neonatal Fc receptor blocker.[1][4]
The most common adverse reactions include headache, infections, diarrhea, pyrexia, hypersensitivity reactions, and nausea.[5]
Rozanolixizumab was approved for medical use in the United States in June 2023.[6][7][8]
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][9]
Society and culture
Names
Rozanolixizumab is the international nonproprietary name.[4]
Legal status
In November 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Rystiggo, intended for the treatment of myasthenia gravis.[10] The applicant for this medicinal product is UCB Pharma.[10]
References
- ^ a b c d "Rystiggo- rozanolixizumab injection, solution". DailyMed. U.S. National Library of Medicine. 30 June 2023. Archived from the original on 29 August 2023. Retrieved 29 August 2023.
- ^ "Rystiggo EPAR". European Medicines Agency. 22 April 2020. Retrieved 18 March 2024.
- ^ "Rystiggo Product information". Union Register of medicinal products. 8 January 2024. Retrieved 18 March 2024.
- ^ a b c World Health Organization (2017). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 77". WHO Drug Information. 31 (1). hdl:10665/330984.
- ^ 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. Archived from the original on 21 January 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. Archived from the original on 28 June 2023. Retrieved 28 June 2023 – via PR Newswire.
- ^ Hoy SM (November 2023). "Correction to: Rozanolixizumab: First Approval". Drugs. 83 (16): 1569. doi:10.1007/s40265-023-01960-y. PMC 10624700. PMID 37861882.
- ^ "Drug Approval Package: Rystiggo". U.S. Food and Drug Administration (FDA). 25 July 2023. Archived from the original on 20 November 2023. Retrieved 20 November 2023.
- ^ a b "Rystiggo: Pending EC decision". European Medicines Agency (EMA). 10 November 2023. Archived from the original on 13 November 2023. Retrieved 5 December 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
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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