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Saphnelo
Published
Product name
Saphnelo
Active ingredient
Anifrolumab
Submission type
New biological entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Saphnelo (anifrolumab) was approved for the following therapeutic use:
Saphnelo (anifrolumab) is indicated as add on treatment of adult patients with moderate to severe, active systemic lupus erythematosus (SLE), despite standard therapy.
The safety and efficacy of Saphnelo have not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus.
How this medicine works
Anifrolumab is a human immunoglobulin G1 kappa monoclonal antibody (IgG1κ) that binds to subunit 1 of the type I interferon receptor (IFNAR1) with high specificity and affinity. This binding inhibits type I IFN signalling thereby blocking the biological activity of type I IFNs. Anifrolumab also induces the internalisation of IFNAR1, thereby reducing the levels of cell surface IFNAR1 available for receptor assembly. Blockade of receptor mediated type I IFN signalling inhibits IFN responsive gene expression as well as downstream inflammatory and immunological processes. Inhibition of type I IFN blocks plasma cell differentiation and normalises peripheral T cell subsets, restoring the balance between adaptive and innate immunity that is dysregulated in multiple autoimmune disorders.Type I IFNs play an important role in the pathogenesis of systemic lupus erythematosus (SLE). Most adult patients with SLE (approximately 60 to 80%) express elevated levels of type I IFN inducible genes, which are associated with increased disease activity and severity.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Saphnelo was considered favourable for the therapeutic use approved.
Sponsor