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APR 27 2026
APPROVED · 95 DAYS AGO

AstraZeneca Saphnelo (anifrolumab) $AZN

for systemic lupus erythematosus

BLA

FDA approved AstraZeneca's Saphnelo Pen autoinjector for once-weekly subcutaneous self-administration in adult SLE patients.

About

Systemic lupus erythematosus is an autoimmune disease where the immune system mistakenly attacks healthy tissue throughout the body, causing painful flares of joint swelling, fatigue, and rashes. Saphnelo (anifrolumab) is an antibody that blocks a key immune signaling protein called type I interferon. By quieting this overactive immune pathway, the drug may help reduce the frequency and severity of disease flares.

Pivotal trial

NCT04931563 Phase 3 completed NCT04931563

The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment regimen of anifrolumab versus placebo in Asian participants with active systemic lupus erythematosus (SLE).

Source: ClinicalTrials.gov

Also in development