Chemistry:Rozanolixizumab
| 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;[2] and is a neonatal Fc receptor blocker.[1][2]
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][6]
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][7]
Society and culture
Names
Rozanolixizumab is the international nonproprietary name.[2]
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.[8] The applicant for this medicinal product is UCB Pharma.[8]
References
- ↑ 1.0 1.1 1.2 1.3 "Rystiggo- rozanolixizumab injection, solution". DailyMed. U.S. National Library of Medicine. 30 June 2023. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3c0eb8c2-c042-4954-b451-3baa77f5e6d1.
- ↑ 2.0 2.1 2.2 "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 77". WHO Drug Information 31 (1). 2017.
- ↑ "FDA Roundup: June 27, 2023". 27 June 2023. https://www.fda.gov/news-events/press-announcements/fda-roundup-june-27-2023.
This article incorporates text from this source, which is in the public domain.
- ↑ "Novel Drug Approvals for 2023". 28 June 2023. https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-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.
- ↑ "Correction to: Rozanolixizumab: First Approval". Drugs 83 (16): 1569. November 2023. doi:10.1007/s40265-023-01960-y. PMID 37861882.
- ↑ "Drug Approval Package: Rystiggo". 25 July 2023. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761286Orig1s000TOC.cfm.
- ↑ 8.0 8.1 "Rystiggo: Pending EC decision". 10 November 2023. https://www.ema.europa.eu/en/medicines/human/summaries-opinion/rystiggo. 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
 |  |
