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 |
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| 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 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.
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]
- ^ a b "Saphnelo APMDS". Therapeutic Goods Administration (TGA). 12 April 2022. Archived from the original on 19 September 2022. Retrieved 24 April 2022.
- ^ "Updates to the Prescribing Medicines in Pregnancy database". Therapeutic Goods Administration (TGA). 21 December 2022. Retrieved 2 January 2023.
- ^ "Notice: Multiple Additions to the Prescription Drug List (PDL) [2022-01-24]". Health Canada. 24 January 2022. Archived from the original on 29 May 2022. Retrieved 28 May 2022.
- ^ "Summary Basis of Decision (SBD) for Saphnelo". Health Canada. 23 October 2014. Archived from the original on 29 May 2022. Retrieved 29 May 2022.
- ^ a b c "Saphnelo- anifrolumab injection, solution". DailyMed. Archived from the original on 12 August 2021. Retrieved 11 August 2021.
- ^ a b "Saphnelo EPAR". European Medicines Agency. 16 December 2021. Archived from the original on 12 April 2022. Retrieved 11 April 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ Statement On A Nonproprietary Name Adopted By The USAN Council - Anifrolumab, American Medical Association.
- ^ "Drug Approval Package: Saphnelo". U.S. Food and Drug Administration (FDA). 17 August 2021. Archived from the original on 12 March 2022. Retrieved 12 March 2022.
- ^ Beitz J (30 July 2021). "Biologics License Application (BLA) for Saphnelo (anifrolumab-fnia) injection" (PDF). Center for Drug Evaluation and Research. Letter to Joelle Blakaitis (AstraZeneca AB). U.S. Food and Drug Administration. Archived from the original (PDF) on 3 August 2021.
- ^ "Saphnelo (Anifrolumab) approved in the US for moderate to severe systemic lupus erythematosus". 2 August 2021. Archived from the original on 2 August 2021. Retrieved 2 August 2021.
- ^ "Saphnelo (anifrolumab) Approved in the US for Moderate to Severe Systemic Lupus Erythematosus" (Press release). AstraZeneca. 2 August 2021. Archived from the original on 2 August 2021. Retrieved 2 August 2021 – via Business Wire.
- ^ Advancing Health Through Innovation: New Drug Therapy Approvals 2021. U.S. Food and Drug Administration (FDA) (Report). 13 May 2022. Archived from the original (PDF) on 6 December 2022. Retrieved 22 January 2023. This article incorporates text from this source, which is in the public domain.