FDA Approves AstraZeneca's Saphnelo Pen for Self-Administration in Lupus Treatment
AstraZeneca's Saphnelo (anifrolumab) has received approval from the U.S. Food and Drug Administration (FDA) for self-administration as a once-weekly autoinjector, known as the Saphnelo Pen, for adults with systemic lupus erythematosus (SLE). This decision follows the successful Phase III TULIP-SC trial, which showed that subcutaneous administration of Saphnelo significantly reduced disease activity in patients with moderate to severe SLE. The trial's findings, published in Arthritis & Rheumatology, confirmed the safety and efficacy of the autoinjector, aligning with the known profile of Saphnelo when given intravenously. This approval is expected to enhance treatment accessibility and convenience for lupus patients.