Treats activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS). NDA 217759, held by Pharming. Leniolisib Phosphate.
As of Nov 13, 2026, NDA 217759 (Joenja), held by Pharming, was first approved by FDA on Mar 24, 2023, with 2 approved supplements and 0 published complete response letters.
JOENJA is indicated for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and pediatric patients 4 years of age and older who weigh 27 kg or greater.
| Sep 11, 2026 | Supplement 6Efficacy (new indication or use) · Priority review | Approved | |
| Mar 24, 2023 | Original applicationNew molecular entity · Priority review | Approved |
| JoenjaEQ 70MG BASE · tablet;oral | Leniolisib Phosphate | RxReference drug |
| JoenjaEQ 40MG BASE · tablet;oral | Leniolisib Phosphate | RxReference drug |
| JoenjaEQ 50MG BASE · tablet;oral | Leniolisib Phosphate | RxReference drug |
| Sep 11, 2026 | Supplement 6Efficacy (new indication or use) · Priority review | Approved | |
| May 28, 2025 | Supplement 5Labeling · Standard review | Approved | |
| Mar 24, 2023 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
