AstraZeneca Secures EU Approval For Subcutaneous Self-Administration Of Saphnelo In Systemic Lupus Erythematosus

AstraZeneca has received European Union approval for subcutaneous self-administration of Saphnelo (anifrolumab) as a pre-filled pen for adult patients with systemic lupus erythematosus (SLE) in addition to standard therapy. The decision by the European Commission follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) and is supported by data from the Phase III TULIP-SC clinical trial.

Professor Thomas Dörner, Rheumatologist and Professor of Rheumatology and Hemostaseology at Charité University Hospital, Berlin, Germany and investigator of the TULIP-SC trial, said: “EU approval of anifrolumab in a self-administered pre-filled pen is fantastic news for people living with systemic lupus erythematosus as clinicians now have the potential to reach a wider group of patients with this important medicine, which has been shown to significantly reduce disease activity and the risk of organ damage. Lupus has historically been overlooked, but with treatment recommendations now aiming for disease remission with earlier use of biologics and less reliance on oral corticosteroids, we’re beginning to see real momentum in delivering higher standards of care.”

In TULIP-SC, subcutaneous administration of Saphnelo demonstrated a statistically significant and clinically meaningful reduction in disease activity compared with placebo in patients with moderate to severe, active, autoantibody-positive SLE receiving standard of care. The results highlight the potential of a more convenient, at-home treatment option while maintaining therapeutic efficacy comparable to intravenous administration.

Jeanette Andersen, Chair of Lupus Europe, said: “Lupus is a devastating disease that primarily impacts young women and is associated with painful symptoms and a substantial impact on daily life. Anifrolumab has been a much-needed innovation in systemic lupus erythematosus and at‑home administration now offers patients a more flexible and convenient option.”

SLE is a chronic autoimmune disease affecting more than 3.4 million people worldwide, predominantly women, and is associated with significant morbidity and increased mortality risk in Europe. Although oral corticosteroids are widely used to manage symptoms, long-term exposure is linked to serious adverse effects and irreversible organ damage. Reducing corticosteroid reliance remains a key treatment goal in modern SLE management strategies.

Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca, said: “We are committed to improving lupus care and since launch, Saphnelo IV infusion has transformed outcomes for tens of thousands of people living with systemic lupus erythematosus. With approximately 70% of SLE patients on biologics in Europe using a subcutaneous self-administration option, today’s approval means we can now offer the clinically meaningful benefits of Saphnelo while expanding patient choice in how and where they receive treatment.”

The safety profile observed in the interim analysis of TULIP-SC was consistent with the established profile of intravenous Saphnelo, with no new safety concerns identified. The interim data were presented at the 2025 American College of Rheumatology Convergence meeting and are expected to be published in a peer-reviewed journal. Subcutaneous Saphnelo is currently under regulatory review in several other regions, including the US and Japan, while the intravenous formulation is approved in more than 70 countries and has been used by over 40,000 patients globally.