The U.S. Food & Drug Administration (FDA) has granted approval for subcutaneous administration of anifrolumab (SAPHNELO) for treatment of people living with moderately to severely active autoantibody-positive systemic lupus erythematosus (SLE). The 120 mg dose of the therapy is administered once weekly via autoinjector alongside standard therapy. The intravenous (IV) administration of SAPHNELO IV infusion was approved for moderate to severe SLE in 2021. The approval by the FDA was based on results from the Phase III TULIP-SC trial, which showed that subcutaneous (SC) administration of Saphnelo led to a statistically significant and clinically meaningful reduction in disease activity compared to placebo in participants with moderate to severe SLE while receiving standard therapy. The safety profile of this route of administration was also consistent with the known safety profile of Saphnelo administered as an IV infusion.
“The FDA approval of self-administered SAPHNELO marks an exciting milestone for people living with lupus,” said Louise Vetter, President and CEO, the Lupus Foundation of America. “Being able to self-inject at home offers greater convenience for those managing SLE, helping to reduce the burden of frequent clinic visits and maintain access to an effective treatment option.”
