Accelerating Product Development for Pediatric Systemic Lupus Erythematosus (SLE) July 30 - 31, 2026

https://www.fda.gov/drugs/news-events-human-drugs/accelerating-product-development-pediatric-systemic-lupus-erythematosus-sle-07302026?utm_medium=email&utm_source=govdelivery FDA Will Host Workshop on Accelerating Product Development for Pediatric Systemic Lupus Erythematosus The U.S. Food and Drug Administration (FDA), with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), will host a workshop, “Accelerating Product Development for Pediatric Systemic Lupus Erythematosus,” on July 30-31, 2026. This workshop will examine key similarities and differences between adult and pediatric systemic lupus erythematosus (SLE) and explore opportunities to leverage strategies, including extrapolation and innovative trial designs, to improve the efficiency and feasibility of pediatric SLE studies. The workshop will foster open dialogue among researchers, clinicians, regulatory authorities, patients and patient advocates, and industry stakeholders to advance therapeutic development for pediatric SLE. SLE is a chronic, multisystem autoimmune disease characterized by inflammation, autoantibody production, and alternating periods of disease flares and remission. Approximately 10-20% of cases have onset during childhood. Currently, only one biologic therapy is approved for pediatric SLE, leaving a substantial unmet need for additional safe and effective treatment options. Conducting clinical trials in pediatric SLE presents several challenges, including a small patient population, limited specialized centers, and difficulties with recruitment and retention. In addition, there is a need to evaluate how existing data, often from adult SLE studies, may be appropriately extrapolated to pediatric populations to streamline drug development and reduce the burden of clinical research in pediatric patients with SLE to ensure timely availability of safe and effective therapies in this population.