10/04/2026
New hope for children with APDS 💙
On September 11, the FDA approved Joenja® (leniolisib) for children ages 4–11 who weigh at least 27 kg (about 60 lb) with activated PI3K-delta syndrome (APDS). It's the first treatment approved for children with this rare inherited immune disorder in the U.S. Until now, it was approved only for ages 12 and up.
Joenja is a pill that targets the overactive immune pathway causing APDS. In the pediatric trial, children had smaller lymph nodes and healthier B-cell counts within 12 weeks. A lower dose for smaller children (13–27 kg) is under priority FDA review, with a decision expected by January 30, 2027.
APDS is often missed for years. Signs include frequent sinus or lung infections, swollen lymph nodes, an enlarged spleen, and autoimmune problems. A simple genetic test can confirm it, and no-charge testing is available for eligible patients.
Questions about your child's immune health? Call us at 813-869-7111.