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APR 27 2026
APPROVED · 37 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 tissues, causing symptoms like joint pain, fatigue, and skin rashes that can flare unpredictably. Saphnelo (anifrolumab) is an antibody that blocks a specific immune signal called type I interferon, which is overactive in lupus and drives the immune system’s attack on the body. By calming this overactive pathway, Saphnelo may help reduce the frequency and severity of lupus flares, offering a potential way to manage this complex condition.

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