AstraZeneca’s Saphnelo has been approved in the U.S.

AstraZeneca’s (AZN) Saphnelo has been approved in the US for self-administration as a once-weekly autoinjector, the Saphnelo Pen, for the treatment of adult patients with systemic lupus erythematosus, SLE, on top of standard therapy. The approval by the US Food and Drug Administration, FDA, was based on results from the Phase III TULIP-SC trial, which showed that subcutaneous, SC, administration of Saphnelo led to a statistically significant and clinically meaningful reduction in disease activity compared to placebo in participants with moderate to severe SLE while receiving standard therapy.1,2 Full results from the TULIP-SC trial were published in Arthritis & Rheumatology in January 2026.