AstraZeneca has received approval from the U.S. Food and Drug Administration for a new self-administered formulation of its lupus treatment, Saphnelo (anifrolumab). The approval introduces the Saphnelo Pen, a once-weekly autoinjector designed for adult patients with Systemic Lupus Erythematosus (SLE), to be used alongside standard therapy.

The decision is based on results from the Phase III TULIP-SC clinical trial, which demonstrated that subcutaneous administration of Saphnelo significantly reduced disease activity compared to placebo in patients with moderate to severe SLE. The study also confirmed a safety profile consistent with the previously approved intravenous formulation.

Saphnelo is a first-in-class monoclonal antibody that targets the type I interferon receptor, a key pathway involved in inflammation in lupus. The new autoinjector format allows patients to administer treatment at home, offering greater flexibility compared to hospital-based intravenous infusions.

Experts say the approval marks an important step forward in improving access and convenience for lupus patients, a group often burdened by chronic symptoms and complex treatment regimens. The condition affects millions globally and can lead to serious complications, including organ damage, if not effectively managed.

The therapy has already been widely adopted in its intravenous form, with tens of thousands of patients treated worldwide. The addition of a subcutaneous option expands treatment choices and aligns with evolving clinical guidelines that emphasise reducing steroid use and achieving sustained disease control.

Saphnelo is currently approved in multiple regions, including the US, Europe and Japan, with further regulatory reviews ongoing. The drug continues to be evaluated for additional autoimmune conditions where interferon pathways play a significant role.

AstraZeneca stated that the new formulation is expected to enhance patient adherence and broaden access to advanced biologic therapies for lupus.