03:57 AM EDT, 04/28/2026 (MT Newswires) -- AstraZeneca (AZN) said Monday the US Food and Drug Administration has approved its Saphnelo subcutaneous autoinjector, allowing once-weekly self-injection for adults with moderate to severe systemic lupus erythematosus on standard therapy.

The Saphnelo Pen approval is supported by phase 3 trial data showing that subcutaneous anifrolumab significantly reduced disease activity compared with placebo, with both statistical and clinical significance, the company said.

The approval expands Saphnelo beyond clinic-based infusions, offering patients more convenient and flexible treatment options, while the IV formulation is already available in over 70 countries worldwide, it added.