First-in-class SAPHNELO Pen now offers greater flexibility and convenience, reaching a wider group of patients

AstraZeneca's SAPHNELO® (anifrolumab-fnia) 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 SAPHNELOled 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. Full results from the TULIP-SC trial were published in Arthritis & Rheumatologyin January 2026.

The safety profile observed was consistent with the known clinical profile of SAPHNELO administered as an intravenous (IV) infusion.

SLE is among the leading causes of death in young women in the US and is more common among Asian, Black or Hispanic populations. While oral corticosteroids are often used to provide relief from SLE symptoms, they are associated with adverse events and do not target the underlying drivers of the disease. Recent updates to clinical guidelines elevate the importance of treating to target remission or low disease activity and minimizing the use of oral corticosteroids.

Subcutaneous administration of SAPHNELO is approved in the EU and Japan and under regulatory review in several other countries around the world. SAPHNELO IV infusion is approved for the treatment of moderate to severe SLE in more than 70 countries worldwide, including the US and EU. To date, more than 40,000 patients globally have been treated with SAPHNELO. SAPHNELOIV is the first biologic with remission data in SLE from a four-year placebo-controlled Phase III trial (TULIP-LTE) and was measured with the DORIS criteria for remission.