FDA Approves AstraZeneca's Saphnelo Autoinjector for Lupus Self-Use in the US
AstraZeneca's Saphnelo (anifrolumab) has received approval from the US Food and Drug Administration (FDA) for self-administration as a once-weekly autoinjector, known as the Saphnelo Pen, for adult patients with systemic lupus erythematosus (SLE). This approval is based on the Phase III TULIP-SC trial results, which demonstrated a significant reduction in disease activity compared to placebo in patients with moderate to severe SLE. The safety profile of the autoinjector is consistent with the intravenous infusion of Saphnelo. The approval is seen as a significant advancement in making the medication more accessible and convenient for patients. SLE is a serious autoimmune condition affecting millions worldwide, and the new administration option offers more flexibility in treatment. 
