Posted by Michael Wonder on 27 Apr 2026
Saphnelo approved in the US for subcutaneous self-administration as a new auto-injector for the treatment of systemic lupus erythematosus
27 April 2026 - AstraZeneca’s Saphnelo (anifrolumab) has been approved in the US for self-administration as a once weekly auto-injector, the Saphnelo Pen, for the treatment of adult patients with systemic lupus erythematosus on top of standard therapy.
The approval by the US FDA was based on results from the Phase 3 TULIP-SC trial, which showed that subcutaneous administration of Saphnelo led to a statistically significant and clinically meaningful reduction in disease activity compared to placebo in participants with moderate to severe systemic lupus erythematosus while receiving standard therapy.
