Anifrolumab

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]}

Anifrolumab

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	US DailyMed: Anifrolumab
Pregnancy category	AU: C[1][2]
Routes of administration	Intravenous
Drug class	type I interferon receptor antagonist (IFN)
ATC code	L04AG11 (WHO)
Legal status
Legal status	AU: S4 (Prescription only)[1] CA: ℞-only / Schedule D[3][4] US: ℞-only[5] EU: Rx-only[6]
Identifiers
CAS Number	1326232-46-5
DrugBank	DB11976
ChemSpider	none
UNII	38RL9AE51Q
KEGG	D11082
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

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.^[14]

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]