Anifrolumab

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Anifrolumab
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetInterferon α/β receptor
Clinical data
Trade namesSaphnelo
Other namesMEDI-546, anifrolumab-fnia
License data
Routes of
administration		Intravenous
Drug class (IFN)
ATC code
  • None
Legal status
Legal status
Identifiers
CAS Number
  • 1326232-46-5
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 (SLE).[1][2] 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 August 2021.[1][3][4][5]

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.[6]

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.[7][8][9]

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.[10] 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.[citation needed]

Names[]

Anifrolumab is the international nonproprietary name (INN).[11]

References[]

  1. ^ Jump up to: a b c "Saphnelo- anifrolumab injection, solution". DailyMed. Retrieved 11 August 2021.
  2. ^ Statement On A Nonproprietary Name Adopted By The USAN Council - Anifrolumab, American Medical Association.
  3. ^ https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761123Orig1s000ltr.pdf
  4. ^ "Saphnelo (Anifrolumab) approved in the US for moderate to severe systemic lupus erythematosus".
  5. ^ "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.
  6. ^ Spreitzer H (29 August 2016). "Neue Wirkstoffe - Anifrolumab". Österreichische Apothekerzeitung (in German) (18/2016).
  7. ^ "Press release: New Hope for Lupus Patients". MedImmune. 11 August 2015. Archived from the original on 31 July 2017.
  8. ^ "Anifrolumab". NHS Specialist Pharmacy Service. Retrieved 31 July 2017.
  9. ^ "Anifrolumab". AdisInsight. Retrieved 31 July 2017.
  10. ^ "Update on TULIP 1 Phase III trial for anifrolumab in systemic lupus erythematosus". www.astrazeneca.com. Retrieved 5 February 2019.
  11. ^ 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[]

  • Anderson E, Furie R (April 2020). "Anifrolumab in systemic lupus erythematosus: current knowledge and future considerations". Immunotherapy. 12 (5): 275–86. doi:10.2217/imt-2020-0017. PMID 32237942.

External links[]

  • "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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