AstraZeneca Secures FDA Approval for Saphnelo Self-Administration in Systemic Lupus Erythematosus

AstraZeneca announced that the U.S. FDA has approved Saphnelo (anifrolumab) for subcutaneous self-administration using a once-weekly autoinjector, expanding treatment options for adults with moderate to severe systemic lupus erythematosus. The approval allows patients to administer the therapy at home instead of receiving intravenous infusions in a clinical setting, improving convenience and access while maintaining a consistent safety profile. The decision was supported by Phase III TULIP-SC trial results showing significant reductions in disease activity compared to placebo on top of standard therapy.