Anifrolumab

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Anifrolumab
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetInterferon α/β receptor
Names
Trade namesSaphnelo
Other namesMEDI-546, anifrolumab-fnia
Clinical data
Drug classType I interferon receptor (IFN) antagonist
Main usesSystemic lupus erythematosus (SLE)[1]
Side effectsUpper respiratory infections, bronchitis[2]
Pregnancy
category
Routes of
use
Intravenous
Typical dose300 mg q 4 weeks[2]
External links
AHFS/Drugs.comMonograph
US NLMAnifrolumab
Legal
License data
Legal status
Chemical and physical data
FormulaC6444H9964N1712O2018S44
Molar mass145119.20 g·mol−1

Anifrolumab, sold under the brand name Saphnelo, is a medication used to treat systemic lupus erythematosus (SLE).[1] Specifically it is used for moderate to severe disease that is not controlled by usual treatments.[1] It is given by injection into a vein.[1]

The most common side effects are upper respiratory infections and bronchitis.[2] Other side effects may include shingles.[2] Safety in pregnancy is unclear.[1] It is a monoclonal antibody that binds to type I interferon receptor, blocking the activity of type I interferons.[2]

Anifrolumab was approved for medical use in the United States in 2021 and Europe in 2022.[1][2] In the United States it costs about 5,000 USD per dose as of 2022.[6] It is not commercially available in the United Kingdom as of 2022.[7]

Medical uses

It decreases disease activity in about 47% of people compared to about 30% who improve without.[2]

Dosage

It is generally given at a dose of 300 mg given over 30 minutes every 4 weeks.[2]

Side effects

The most common side 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]

Mechanism of Action

In systemic lupus erythematous, 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 INF-1 from sending signals to other immune cells, which prevents the body from being attacked by itself.[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]

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 (SLE).[2] The applicant for this medicinal product is AstraZeneca AB.[2] Anifrolumab was approved for medical use in the European Union in February 2022.[2]

Names

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

References

  1. 1.0 1.1 1.2 1.3 1.4 1.5 1.6 "Saphnelo- anifrolumab injection, solution". DailyMed. Archived from the original on 12 August 2021. Retrieved 11 August 2021.
  2. 2.00 2.01 2.02 2.03 2.04 2.05 2.06 2.07 2.08 2.09 2.10 2.11 "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.
  3. 3.0 3.1 "Saphnelo APMDS". Therapeutic Goods Administration (TGA). 12 April 2022. Archived from the original on 19 September 2022. Retrieved 24 April 2022.
  4. "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.
  5. "Summary Basis of Decision (SBD) for Saphnelo". Health Canada. Archived from the original on 29 May 2022. Retrieved 29 May 2022.
  6. "Saphnelo Prices, Coupons, Copay & Patient Assistance". Drugs.com. Retrieved 29 October 2022.
  7. "Anifrolumab". SPS - Specialist Pharmacy Service. 23 December 2015. Archived from the original on 31 July 2017. Retrieved 29 October 2022.
  8. Spreitzer H (29 August 2016). "Neue Wirkstoffe - Anifrolumab". Österreichische Apothekerzeitung (in Deutsch) (18/2016).
  9. Bui, Albert; Sanghavi, Devang (2022), "Anifrolumab", StatPearls, Treasure Island (FL): StatPearls Publishing, PMID 32310439, retrieved 11 June 2022
  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. Archived from the original on 31 July 2017. Retrieved 31 July 2017.
  12. "Anifrolumab". AdisInsight. Archived from the original on 31 July 2017. Retrieved 31 July 2017.
  13. 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

External links

Identifiers:
  • "Anifrolumab". Drug Information Portal. U.S. National Library of Medicine. Archived from the original on 21 November 2021. Retrieved 20 October 2022.
  • 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