Anifrolumab

Anifrolumab, sold under the brand name Saphnelo, is a monoclonal antibody used for the treatment of systemic lupus erythematosus (SLE).[2][4] It binds to the type I interferon receptor, blocking the activity of type I interferons such as interferon-α and interferon-β.

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 was approved for medical use in the United States in July 2021.[2][5][6][7][8]

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.[9]

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.[10][11][12]

Clinical trial results

Anifrolumab failed to meet its endpoint of significant reduction in disease as assessed by the SLE Responder Index 4 instrument in the TULIP 1 phase III trial.[13] This multi-center, double-blind, placebo-controlled study followed adults with moderate to severe SLE over the course of one year. Preliminary results were announced on 31 August 2018.

Society and culture

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 (SLE).[14] The applicant for this medicinal product is AstraZeneca AB.[14] Anifrolumab was approved for medical use in the European Union in February 2022.[3]

Names

Anifrolumab is the international nonproprietary name (INN).[15]

References
  1. "Saphnelo". Therapeutic Goods Administration (TGA). 12 April 2022. Retrieved 24 April 2022.
  2. "Saphnelo- anifrolumab injection, solution". DailyMed. Retrieved 11 August 2021.
  3. "Saphnelo EPAR". European Medicines Agency. 16 December 2021. Retrieved 11 April 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  4. Statement On A Nonproprietary Name Adopted By The USAN Council - Anifrolumab, American Medical Association.
  5. "Drug Approval Package: Saphnelo". U.S. Food and Drug Administration (FDA). 17 August 2021. Retrieved 12 March 2022.
  6. 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.
  7. "Saphnelo (Anifrolumab) approved in the US for moderate to severe systemic lupus erythematosus".
  8. "Saphnelo (anifrolumab) Approved in the US for Moderate to Severe Systemic Lupus Erythematosus" (Press release). AstraZeneca. 2 August 2021. Retrieved 2 August 2021 – via Business Wire.
  9. Spreitzer H (29 August 2016). "Neue Wirkstoffe - Anifrolumab". Österreichische Apothekerzeitung (in German) (18/2016).
  10. "Press release: New Hope for Lupus Patients". MedImmune. 11 August 2015. Archived from the original on 31 July 2017.
  11. "Anifrolumab". NHS Specialist Pharmacy Service. 23 December 2015. Retrieved 31 July 2017.
  12. "Anifrolumab". AdisInsight. Retrieved 31 July 2017.
  13. "Update on TULIP 1 Phase III trial for anifrolumab in systemic lupus erythematosus". www.astrazeneca.com. Retrieved 5 February 2019.
  14. "Saphnelo: Pending EC decision". European Medicines Agency. 16 December 2021. Retrieved 18 December 2021. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  15. World Health Organization (2014). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 71". WHO Drug Information. 28 (1). hdl:10665/331151.

Further reading
  • "Anifrolumab". Drug Information Portal. U.S. National Library of Medicine.
  • 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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