First Pediatric Treatment for Activated PI3K Delta Syndrome (APDS) Approved by FDA

The FDA has approved Pharming's Joenja® (leniolisib) as the first specific treatment for children diagnosed with Activated PI3K Delta Syndrome (APDS) in the U.S. This rare primary immunodeficiency leads to recurrent infections and immune dysregulation. The approval provides a crucial new therapeutic option, addressing a significant unmet medical need for this pediatric patient population.