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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 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]

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 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]

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]

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]

Anifrolumab is the international nonproprietary name (INN).^[19]

^ Advancing Health Through Innovation: New Drug Therapy Approvals 2021 (PDF). U.S. Food and Drug Administration (FDA) (Report). 13 May 2022. Archived from the original on 6 December 2022. Retrieved 22 January 2023. This article incorporates text from this source, which is in the public domain.

• 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.

• 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