Anifrolumab

Anifrolumab

Monoclonal antibody
Type	Whole antibody
Source	Human
Target	Interferon α/β receptor
Clinical data
Trade names	Saphnelo
Other names	MEDI-546, anifrolumab-fnia
AHFS/Drugs.com	Monograph
License data	US DailyMed: Anifrolumab
Pregnancy category	AU: C[1][2]
Routes of administration	Intravenous
Drug class	type I interferon receptor antagonist (IFN)
ATC code	L04AG11 (WHO)
Legal status
Legal status	AU: S4 (Prescription only)[1] CA: ℞-only / Schedule D[3][4] US: ℞-only[5] EU: Rx-only[6]
Identifiers
CAS Number	1326232-46-5
DrugBank	DB11976
ChemSpider	none
UNII	38RL9AE51Q
KEGG	D11082
Chemical and physical data
Formula	C6444H9964N1712O2018S44
Molar mass	145119.20 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.^{[medical citation needed]}

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. "Saphnelo APMDS". Therapeutic Goods Administration (TGA). 12 April 2022. Archived from the original on 19 September 2022. Retrieved 24 April 2022.
2. "Updates to the Prescribing Medicines in Pregnancy database". Therapeutic Goods Administration (TGA). 21 December 2022. Retrieved 2 January 2023.
3. "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.
4. "Summary Basis of Decision (SBD) for Saphnelo". Health Canada. 23 October 2014. Archived from the original on 29 May 2022. Retrieved 29 May 2022.
5. "Saphnelo- anifrolumab injection, solution". DailyMed. Archived from the original on 12 August 2021. Retrieved 11 August 2021.
6. "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.
7. Statement On A Nonproprietary Name Adopted By The USAN Council - Anifrolumab, American Medical Association.
8. "Drug Approval Package: Saphnelo". U.S. Food and Drug Administration (FDA). 17 August 2021. Archived from the original on 12 March 2022. Retrieved 12 March 2022.
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". Archived from the original on 2 August 2021. Retrieved 2 August 2021.
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. Advancing Health Through Innovation: New Drug Therapy Approvals 2021 (PDF). U.S. Food and Drug Administration (FDA) (Report). 13 May 2022. Archived from the original on 6 December 2022. Retrieved 22 January 2023. This article incorporates text from this source, which is in the public domain.
13. Bui A, Sanghavi D (2022). "Anifrolumab". StatPearls. Treasure Island (FL): StatPearls Publishing. PMID 32310439. Retrieved 11 June 2022.
14. Spreitzer H (29 August 2016). "Neue Wirkstoffe - Anifrolumab". Österreichische Apothekerzeitung (in German) (18/2016).
15. "Press release: New Hope for Lupus Patients". MedImmune. 11 August 2015. Archived from the original on 31 July 2017.
16. "Anifrolumab". NHS Specialist Pharmacy Service. 23 December 2015. Archived from the original on 31 July 2017. Retrieved 31 July 2017.
17. "Anifrolumab". AdisInsight. Archived from the original on 31 July 2017. Retrieved 31 July 2017.
18. "Saphnelo Product information". Union Register of medicinal products. Retrieved 3 March 2023.
19. 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): 275–286. doi:10.2217/imt-2020-0017. PMID 32237942. S2CID 214768375.

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