| 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 |
| License data | |
| Pregnancy category | |
| Routes of administration | Intravenous |
| Drug class | type I interferon receptor antagonist (IFN) |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| ChemSpider |
|
| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C6444H9964N1712O2018S44 |
| Molar mass | 145119.20 g·mol−1 |
Anifrolumab, sold under the brand nameSaphnelo, is amonoclonal antibody used for the treatment ofsystemic lupus erythematosus.[5][7] It binds to thetype I interferon receptor, blocking the activity oftype I interferons such as interferon-α and interferon-β.[medical citation needed]
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 afirst-in-class medication.[12]
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]
The most common adverse effect wasshingles, which occurred in 5% of patients in the low-dose group, to 10% in the high-dose group, and to 2% in theplacebo group. Overall adverse effect rates were comparable in all groups.[14]
The drug was developed byMedImmune, a unit ofAstraZeneca, which chose to move anifrolumab instead ofsifalimumab into phase III trials for lupus in 2015.[15][16][17]
On 16 December 2021, 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 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]
Anifrolumab is the international nonproprietary name (INN).[19]
This article incorporates text from this source, which is in thepublic domain.
