FDA Approves Joenja as First Treatment for Young Children with APDS

The FDA has approved Pharming's Joenja (leniolisib) as the first treatment for children aged 4 to 11 years with activated phosphoinositide 3-kinase delta syndrome (APDS), a rare primary immunodeficiency. This approval, following positive supplemental New Drug Application results, expands Joenja's indication beyond older patients. New doses are expected to be available in October.