AstraZeneca’s Saphnelo autoinjector gains FDA approval for weekly self-administration in systemic lupus erythematosus, supported by Phase III TULIP-SC data.
Written By: Vennela Reddy, BPharm
Reviewed By: Pharmacally Editorial Team
AstraZeneca has received approval from the US Food and Drug Administration for a subcutaneous, once-weekly autoinjector version of Saphnelo (anifrolumab) for adults with systemic lupus erythematosus (SLE), to be used alongside standard therapy. The newly approved Saphnelo Pen allows patients to self-administer treatment outside clinical settings, offering an alternative to the existing intravenous infusion.
The approval is supported by results from the Phase III TULIP-SC trial (NCT04877691) in patients with moderate to severe SLE receiving standard care, where subcutaneous anifrolumab demonstrated a statistically significant and clinically meaningful reduction in disease activity compared with placebo, as measured by the British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA) response at 52 weeks.
The study also showed earlier achievement of treatment response, reduction in disease activity while tapering oral corticosteroids to low doses, and a numerical delay in time to first flare.
In secondary analyses, 29.0% of patients achieved remission based on DORIS criteria and 40.1% reached low disease activity status, while the safety profile was consistent with the established intravenous formulation.
Full results from the TULIP-SC trial were published in Arthritis & Rheumatology in January 2026.
Investigators and stakeholders highlighted the clinical and practical implications of the new formulation.
Susan Manzi, MD, principal investigator of the trial, indicated “The approval of anifrolumab as a self-administered autoinjector is exciting news as it makes this important medicine more convenient and accessible for many more patients. With its proven ability to significantly reduce disease activity and the risk of organ damage, anifrolumab has been a much-needed innovation in lupus, which is a serious and often debilitating autoimmune condition impacting millions worldwide.”
Louise Vetter, CEO of the Lupus Foundation of America, noted “The FDA approval of a subcutaneous administration option for anifrolumab is an exciting milestone for the lupus community because it offers people with systemic lupus erythematosus more convenience and choice of where and how they want to receive treatment.”
Ruud Dobber Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca stated “Since its launch, Saphnelo IV infusion has helped tens of thousands of people with systemic lupus erythematosus achieve lower disease activity with fewer steroids and has been shown to help many achieve remission. The approval of the Saphnelo Pen represents a significant step forward in expanding Saphnelo’s clinical benefits to more people living with systemic lupus erythematosus.”
SLE is a chronic autoimmune disease affecting more than 3.4 million people globally and disproportionately impacts women, with standard treatments such as corticosteroids associated with long-term toxicity and limited effect on underlying disease mechanisms.
Anifrolumab is a monoclonal antibody targeting the type I interferon receptor, a key pathway in SLE pathogenesis. The subcutaneous formulation is already approved in the EU and Japan and under review in other regions, while the intravenous version is approved in more than 70 countries and has been used in over 40,000 patients worldwide.
Reference
Manzi, S et al, Efficacy and Safety of Subcutaneous Anifrolumab in Systemic Lupus Erythematosus: A Randomized, Phase 3 Study. Arthritis Rheumatol. https://doi.org/10.1002/art.70041
About the Writer
Vennela Reddy, B Pharm is a pharmacy graduate with a keen interest in clinical research, pharmacovigilance, and medical writing, with a growing focus on publishable and scientific content development. In her words, she is passionate about translating complex medical data into clear, evidence-based communication.