| 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 nameRystiggo, is amonoclonal antibody used for the treatment ofmyasthenia gravis.[3] Rozanolixizumab is a humanized and chimeric monoclonal antibody;[6] and is a neonatal Fc receptor blocker.[3][6]
The most common adverse reactions include headache, infections, diarrhea, pyrexia, hypersensitivity reactions, and nausea.[7]
Rozanolixizumab was approved for medical use in the United States in June 2023,[8][9][10] and in the European Union in January 2024.[4]
Rozanolixizumab isindicated for the treatment of generalized myasthenia gravis in adults who are anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibody positive.[3][11]
Rozanolixizumab is theinternational nonproprietary name.[6]
In November 2023, theCommittee for Medicinal Products for Human Use (CHMP) of theEuropean 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.[12] The applicant for this medicinal product is UCB Pharma.[12] Rozanolixizumab was approved for medical use in the European Union in January 2024.[4][5]
This article incorporates text from this source, which is in thepublic domain.
