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FDA accepts Priority Review of Pharming's supplemental application for lower Joenja doses in children weighing 13 to 27 kg, targeting action by January 30, 2027
PHARPharming Group N.V.
Pharming Group N.V. announced that the U.S. Food and Drug Administration has accepted its supplemental New Drug Application for lower doses of Joenja (leniolisib) to treat children aged 4 years and older with activated phosphoinositide 3-kinase delta syndrome who weigh between 13 kg and 27 kg. The application received Priority Review designation, establishing a Prescription Drug User Fee Act target action date of January 30, 2027. This expansion follows the September 2026 approval for children aged 4 to 11 years weighing at least 27 kg. Pharming Group N.V. is a global biotechnology company that develops and commercializes innovative medicines for rare immune and genetic diseases.