| 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 |
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| Pregnancy category |
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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, sold under the brand name Saphnelo, is a monoclonal antibody used for the treatment of systemic lupus erythematosus (SLE). It binds to the type I interferon receptor, blocking the activity of type I interferons such as interferon-α and interferon-β.
Anifrolumab was approved for medical use in the United States in July 2021, and in the European Union in February 2022. The U.S. Food and Drug Administration considers it to be a first-in-class medication.
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 INF-1 from sending signals to other immune cells, which prevents the body from being attacked by itself.
Adverse effects
The most common adverse effect was shingles, which occurred in 5% of patients in the low-dose group, to 10% in the high-dose group, and to 2% in the placebo group. Overall adverse effect rates were comparable in all groups.
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.
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 (SLE). The applicant for this medicinal product is AstraZeneca AB. Anifrolumab was approved for medical use in the European Union in February 2022.
Names
Anifrolumab is the international nonproprietary name (INN).
Further reading
- Anderson E, Furie R (April 2020). "Anifrolumab in systemic lupus erythematosus: current knowledge and future considerations". Immunotherapy. 12 (5): 275–286. doi:10.2217/imt-2020-0017. PMID 32237942. S2CID 214768375.
External links
- "Anifrolumab". Drug Information Portal. U.S. National Library of Medicine.
- Clinical trial number NCT01438489 for "A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus Erythematosus" at ClinicalTrials.gov
- Clinical trial number NCT02446912 for "Efficacy and Safety of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus" at ClinicalTrials.gov
- Clinical trial number NCT02446899 for "Efficacy and Safety of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus" at ClinicalTrials.gov
