Shots:
- The US FDA has approved Joenja (leniolisib; 40 & 50mg, BID, PO) for the treatment of children (4-11yrs.; ≥27kg) with activated phosphoinositide 3-kinase delta (APKD) syndrome
- Approval was backed by a P-III trial in APKD pediatric pts (4-11yrs.), which showed reduced lymphadenopathy & increased naïve B cells over 12wks. with a favorable safety profile
- The new Joenja doses are expected to reach eligible US pediatric pts in Oct 2026, while a separate sNDA for lower doses in children aged 4–11yrs. weighing 13 to <27kg was submitted on July 30, 2026
Ref: Globenewswire | Image: Pharming | Press Release
PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us at connect@pharmashots.com
