Anifrolumab Explained

Anifrolumab, sold under the brand name Saphnelo, is a monoclonal antibody used for the treatment of systemic lupus erythematosus.[1] 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,[2] [3] [4] [5] and in the European Union in February 2022. The U.S. Food and Drug Administration considers it to be a first-in-class medication.[6]

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.[7]

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.[8]

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.[9] [10] [11]

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. The applicant for this medicinal product is AstraZeneca AB. Anifrolumab was approved for medical use in the European Union in February 2022.[12]

Names

Anifrolumab is the international nonproprietary name (INN).[13]

Further reading

Notes and References

  1. http://www.ama-assn.org/resources/doc/usan/anifrolumab.pdf Statement On A Nonproprietary Name Adopted By The USAN Council - Anifrolumab
  2. Web site: Drug Approval Package: Saphnelo . U.S. Food and Drug Administration (FDA) . 17 August 2021 . 12 March 2022 . 12 March 2022 . https://web.archive.org/web/20220312071007/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/761123Orig1s000TOC.cfm . live .
  3. Beitz J . Center for Drug Evaluation and Research . U.S. Food and Drug Administration . Biologics License Application (BLA) for Saphnelo (anifrolumab-fnia) injection . Joelle Blakaitis (AstraZeneca AB) . 30 July 2021 . https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761123Orig1s000ltr.pdf.
  4. Web site: Saphnelo (Anifrolumab) approved in the US for moderate to severe systemic lupus erythematosus. 2 August 2021. 2 August 2021. https://web.archive.org/web/20210802092746/https://www.astrazeneca.com/media-centre/press-releases/2021/saphnelo-approved-in-the-us-for-sle.html. live.
  5. Saphnelo (anifrolumab) Approved in the US for Moderate to Severe Systemic Lupus Erythematosus . AstraZeneca . Business Wire . 2 August 2021 . 2 August 2021 . 2 August 2021 . https://web.archive.org/web/20210802111722/http://www.businesswire.com/news/home/20210802005199/en/SAPHNELO-anifrolumab-Approved-in-the-US-for-Moderate-to-Severe-Systemic-Lupus-Erythematosus/ . live .
  6. Advancing Health Through Innovation: New Drug Therapy Approvals 2021 . U.S. Food and Drug Administration (FDA) . 13 May 2022 . PDF . 22 January 2023 . 6 December 2022 . https://web.archive.org/web/20221206210020/https://www.fda.gov/media/155227/download . live .
  7. Book: Bui A, Sanghavi D . Anifrolumab . 2022 . https://www.ncbi.nlm.nih.gov/books/NBK555979/ . StatPearls . Treasure Island (FL) . StatPearls Publishing . 32310439 . 11 June 2022 .
  8. Spreitzer H . 29 August 2016 . Neue Wirkstoffe - Anifrolumab . Österreichische Apothekerzeitung . 18/2016 . de .
  9. Web site: Press release: New Hope for Lupus Patients. MedImmune. https://web.archive.org/web/20170731052844/https://www.medimmune.com/about-us/media/new-hope-for-lupus-patients-20150811.html. 31 July 2017. 11 August 2015.
  10. Web site: Anifrolumab. 23 December 2015. NHS Specialist Pharmacy Service. 31 July 2017. 31 July 2017. https://web.archive.org/web/20170731122017/https://www.sps.nhs.uk/medicines/anifrolumab/. live.
  11. Web site: Anifrolumab. AdisInsight. 31 July 2017. 31 July 2017. https://web.archive.org/web/20170731104555/http://adisinsight.springer.com/drugs/800021494. live.
  12. Web site: Saphnelo Product information . Union Register of medicinal products . 3 March 2023.
  13. ((World Health Organization)) . 2014 . International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 71 . WHO Drug Information . 28 . 1 . 10665/331151 . free .

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