Chemistry:Anifrolumab

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Short description: Monoclonal antibody
Anifrolumab
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetInterferon α/β receptor
Clinical data
Trade namesSaphnelo
Other namesMEDI-546, anifrolumab-fnia
AHFS/Drugs.comMonograph
License data
Pregnancy
category
Routes of
administration		Intravenous
Drug classtype I interferon receptor antagonist (IFN)
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
Chemical and physical data
FormulaC6444H9964N1712O2018S44
Molar mass145119.20 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]

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]

References

  1. ↑ 1.0 1.1 "Saphnelo APMDS". 12 April 2022. https://www.tga.gov.au/resources/auspmd/saphnelo. 
  2. ↑ "Updates to the Prescribing Medicines in Pregnancy database". 21 December 2022. https://www.tga.gov.au/resources/resource/guidance/updates-prescribing-medicines-pregnancy-database. 
  3. ↑ "Notice: Multiple Additions to the Prescription Drug List (PDL) [2022-01-24"]. 24 January 2022. https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/prescription-drug-list/notices-changes/multiple-additions-2022-01-24.html. 
  4. ↑ "Summary Basis of Decision (SBD) for Saphnelo". 23 October 2014. https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00575&lang=en. 
  5. ↑ 5.0 5.1 5.2 "Saphnelo- anifrolumab injection, solution". https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d6203302-2128-41a7-b0b4-0e6c0704d4dc. 
  6. ↑ 6.0 6.1 6.2 6.3 6.4 "Saphnelo EPAR". 16 December 2021. https://www.ema.europa.eu/en/medicines/human/EPAR/saphnelo.  Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  7. ↑ Statement On A Nonproprietary Name Adopted By The USAN Council - Anifrolumab, American Medical Association.
  8. ↑ "Drug Approval Package: Saphnelo". 17 August 2021. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/761123Orig1s000TOC.cfm. 
  9. ↑ 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.
  10. ↑ "Saphnelo (Anifrolumab) approved in the US for moderate to severe systemic lupus erythematosus". https://www.astrazeneca.com/media-centre/press-releases/2021/saphnelo-approved-in-the-us-for-sle.html. 
  11. ↑ "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.
  12. ↑ (PDF) Advancing Health Through Innovation: New Drug Therapy Approvals 2021 (Report). 13 May 2022. https://www.fda.gov/media/155227/download. Retrieved 22 January 2023.  This article incorporates text from this source, which is in the public domain.
  13. ↑ "Anifrolumab". StatPearls. Treasure Island (FL): StatPearls Publishing. 2022. https://www.ncbi.nlm.nih.gov/books/NBK555979/. Retrieved 11 June 2022. 
  14. ↑ "Neue Wirkstoffe - Anifrolumab" (in de). Österreichische Apothekerzeitung (18/2016). 29 August 2016. 
  15. ↑ "Press release: New Hope for Lupus Patients". MedImmune. 11 August 2015. https://www.medimmune.com/about-us/media/new-hope-for-lupus-patients-20150811.html. 
  16. ↑ "Anifrolumab". NHS Specialist Pharmacy Service. 23 December 2015. https://www.sps.nhs.uk/medicines/anifrolumab/. 
  17. ↑ "Anifrolumab". AdisInsight. http://adisinsight.springer.com/drugs/800021494. 
  18. ↑ "Saphnelo Product information". https://ec.europa.eu/health/documents/community-register/html/h1623.htm. 
  19. ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 71". WHO Drug Information 28 (1). 2014. 

Further reading

  • "Anifrolumab in systemic lupus erythematosus: current knowledge and future considerations". Immunotherapy 12 (5): 275–286. April 2020. doi:10.2217/imt-2020-0017. PMID 32237942. 

External links

  • 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



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