AstraZeneca has received approval from the European Commission for subcutaneous self-administration of Saphnelo (anifrolumab) using a pre-filled pen for adult patients with systemic lupus erythematosus, in addition to standard therapy.

The approval follows a positive opinion from the Committee for Medicinal Products for Human Use and is supported by results from the Phase III TULIP-SC trial. The study demonstrated that subcutaneous administration of Saphnelo led to a statistically significant and clinically meaningful reduction in disease activity compared with placebo in patients with moderate to severe, active, autoantibody-positive systemic lupus erythematosus receiving standard treatment.

Systemic lupus erythematosus is a chronic and debilitating autoimmune disease affecting more than 3.4 million people worldwide, predominantly women. In Europe, patients with lupus face a two- to three-fold higher risk of mortality compared with the general population. While oral corticosteroids are commonly used to manage symptoms, they are associated with long-term adverse effects and do not address the underlying drivers of the disease.

The newly approved formulation allows patients to self-administer a once-weekly 120 mg dose using a pre-filled pen, offering greater flexibility and convenience compared with intravenous infusion administered in hospitals or clinics. Since 2021, Saphnelo has been available in Europe as an intravenous treatment.

The safety profile observed in the TULIP-SC trial was consistent with that of the intravenous formulation. Interim trial results were presented at the American College of Rheumatology Convergence 2025 meeting, with full results expected to be published in a peer-reviewed medical journal.

AstraZeneca stated that the approval expands patient choice while maintaining the clinically meaningful benefits already established with Saphnelo. The company noted that a significant proportion of biologic-treated lupus patients in Europe prefer subcutaneous administration, making this option particularly relevant for real-world use.

Subcutaneous administration of Saphnelo is currently under regulatory review in other regions, including the United States and Japan. The intravenous formulation is approved for the treatment of moderate to severe systemic lupus erythematosus in more than 70 countries globally, and more than 40,000 patients worldwide have been treated with Saphnelo to date.

Saphnelo is a first-in-class, fully human monoclonal antibody that blocks type I interferon receptor signalling, a key pathway implicated in lupus disease activity. AstraZeneca continues to evaluate anifrolumab across multiple immune-mediated diseases where type I interferon plays a central role.