[REVISION HISTORY]

Joenja pediatric expansion for APDS

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What changed

2026-09-11 22:07 UTC → 2026-09-12 02:14 UTC · added ~~removed~~

The pharmaceutical company Pharming has expanded the availability of Joenja (leniolisib) for pediatric patients with activated PI3K delta syndrome (APDS) in different global markets. In August 2026, Japan became the first market to commercially launch Joenja for children aged 4 to 11 following approval by the Ministry of Health, Labour and Welfare. Under an agreement with OrphanPacific, Inc., the medication is being distributed to address symptoms such as recurrent infections and lymph node swelling. By September 2026, the U.S. Food and Drug Administration approved Joenja for children aged 4 to 11 weighing at least 27 kg. This approval followed multinational Phase 3 studies showing improvements in lymphadenopathy and naïve B cell levels. The FDA noted that Joenja is the first approved treatment for this specific pediatric age group. The safety profile was reported to be consistent with previous experience, with treatment-emergent adverse events being mild to moderate. Pharming expects to make the 40 mg and 50 mg doses available in the United States starting in October. Additionally, the company has submitted a separate application for lower dosages intended for children in the same age group who weigh between 13 kg and 27 kg.

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