Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2021 Oct;81(15):1795-1802.
doi: 10.1007/s40265-021-01604-z.

Anifrolumab: First Approval

Emma D Deeks  1
Affiliations
Review

Anifrolumab: First Approval

Emma D Deeks. Drugs. 2021 Oct.

Abstract

Anifrolumab (anifrolumab-fnia; Saphnelo™) is a monoclonal antibody antagonist of the type 1 interferon receptor (IFNAR). It is being developed by AstraZeneca (under license from Medarex, now Bristol-Myers Squibb) for the treatment of autoimmune disorders, including systemic lupus erythematosus (SLE) and lupus nephritis, the underlying pathogenesis of which involves type 1 interferon. In July 2021, intravenous anifrolumab was approved in the USA for the treatment of adult patients with moderate to severe SLE who are receiving standard therapy. Anifrolumab (intravenous or subcutaneous) continues to be assessed in clinical studies in SLE in various countries, and the intravenous formulation is under regulatory review in the EU and Japan. This article summarizes the milestones in the development of anifrolumab leading to this first approval for the treatment of moderate to severe SLE.

PubMed Disclaimer

References

    1. Justiz Vaillant AA, Goyal A, Bansal P, et al. Systemic lupus erythematosus [online book]. 2020. https://www.ncbi.nlm.nih.gov/books/NBK535405/#article-24526.s2 . Accessed 11 Aug 2021.
    1. Ronnblom L, Leonard D. Interferon pathway in SLE: one key to unlocking the mystery of the disease. Lupus Sci Med. 2019;6(1):e000270. - DOI
    1. AstraZeneca. Saphnelo (anifrolumab-fnia): US prescribing information. 2021. https://www.accessdata.fda.gov/ . Accessed 11 Aug 2021.
    1. AstraZeneca. Saphnelo (anifrolumab) approved in the US for moderate to severe systemic lupus erythematosus [media release]. 2 Aug 2021. https://www.astrazeneca.com .
    1. MedImmune Inc. MedImmune and Medarex announce collaboration to develop and commercialize fully human antibodies for autoimmune diseases [media release]. 23 Nov 2004. http://www.medimmune.com .

MeSH terms

Substances

LinkOut - more resources