Anifrolumab
Monoclonal antibody
From Wikipedia, the free encyclopedia
Anifrolumab, sold under the brand name Saphnelo, is a monoclonal antibody used for the treatment of systemic lupus erythematosus.[5][7] It binds to the type I interferon receptor, blocking the activity of type I interferons such as interferon-α and interferon-β.[medical citation needed]
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Human |
| Target | Interferon α/β receptor |
| Clinical data | |
| Trade names | Saphnelo |
| Other names | MEDI-546, anifrolumab-fnia |
| AHFS/Drugs.com | Monograph |
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| Routes of administration | Intravenous |
| Drug class | type I interferon receptor antagonist (IFN) |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| ChemSpider |
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| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C6444H9964N1712O2018S44 |
| Molar mass | 145119.20 g·mol−1 |
Anifrolumab was approved for medical use in the United States in July 2021,[5][8][9][10][11] and in the European Union in February 2022.[6] The U.S. Food and Drug Administration considers it to be a first-in-class medication.[12]
Mechanism of Action
In systemic lupus erythematosus, the body can produce a great amount of type 1 interferon, which activates the immune system excessively and creates problems for lupus patients. Anifrolumab acts to block IFN-1 from sending signals to other immune cells, which prevents the body from being attacked by itself.[13]
Adverse effects
History
The drug was developed by MedImmune, a unit of AstraZeneca, which chose to move anifrolumab instead of sifalimumab into phase III trials for lupus in 2015.[15][16][17]
Society and culture
Legal status
On 16 December 2021, 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 Saphnelo, intended for the treatment of moderate to severe systemic lupus erythematosus.[6] The applicant for this medicinal product is AstraZeneca AB.[6] Anifrolumab was approved for medical use in the European Union in February 2022.[6][18]
Names
Anifrolumab is the international nonproprietary name (INN).[19]
