Biopharmaceutical company AstraZeneca PLC (LSE: AZN) (STO: AZN) (NYSE: AZN) declared on Monday that it has received US Food and Drug Administration approval for the subcutaneous self-administration of Saphnelo (anifrolumab) via a once-weekly autoinjector, expanding treatment options for adult patients with systemic lupus erythematosus (SLE).

The newly approved Saphnelo Pen enables patients to self-administer therapy, offering increased flexibility and convenience compared with the existing intravenous formulation. The approval was supported by data from the Phase III TULIP-SC trial, which demonstrated a statistically significant and clinically meaningful reduction in disease activity versus placebo in patients with moderate to severe SLE receiving standard therapy. The safety profile was consistent with the established profile of the intravenous formulation.

Saphnelo is a first-in-class monoclonal antibody targeting the type I interferon receptor and is designed to address underlying disease drivers rather than solely managing symptoms. The treatment has already been approved for subcutaneous use in the EU and Japan, while the intravenous formulation is authorised in more than 70 countries.

AstraZeneca noted that SLE affects over 3.4 million people globally and remains a leading cause of death among young women in the US. The company continues to evaluate Saphnelo across multiple indications where type I interferon plays a role, supporting its broader strategy in immune-mediated diseases.