FDA approves Saphnelo Pen for self-administration in adults with SLE
The FDA approved AstraZeneca’s Saphnelo Pen for once-weekly self-administration in adults with systemic lupus erythematosus. Approval was based on Phase III TULIP-SC results showing reduced disease activity versus placebo.
The US Food and Drug Administration (FDA) has approved Saphnelo (anifrolumab) 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 was based on results from the Phase III 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 SLE while receiving standard therapy. The safety profile observed was consistent with the known clinical profile of Saphnelo administered as an intravenous infusion.
Full results from the TULIP-SC trial were published in Arthritis & Rheumatology in January 2026. The original BLA submission included data from the TULIP-SC study, which assessed the safety and efficacy of a subcutaneous treatment regimen of anifrolumab vs placebo in patients with moderately to severely active, autoantibody-positive SLE despite receiving standard of care treatment.
The trial included patients aged 18 to 70 years who were taking one or any combination of oral corticosteroids, antimalarial, and/or immunosuppressants. Study participants (N=367) were randomly assigned 1:1 to receive anifrolumab 120mg subcutaneously (n=184) or placebo (n=183) once weekly using a prefilled syringe. The primary endpoint was a reduction in disease activity as measured by the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) at week 52.
Findings at week 52 showed 56.2% of patients treated with anifrolumab SC achieved a statistically significant and clinically meaningful reduction in disease activity compared with 37.1% of placebo patients, with a treatment difference of 19.1% (95% CI, 9.0-29.2; P=.0002). Significant improvements in key secondary endpoints were also observed.
SLE is amongst the leading causes of death in young women in the US and is more common amongst 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 minimising 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 intravenous 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. Saphnelo IV 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.
AstraZeneca acquired global rights to Saphnelo through an exclusive license and collaboration agreement with Medarex in 2004. Under the agreement, updated in 2025, AstraZeneca will pay Bristol-Myers Squibb a mid-teens royalty for sales in the US.