Pharming announces U.S. FDA acceptance of sNDA resubmission for Joenja® (leniolisib) to treat children aged 4 to 11 years with APDS

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Pharming says the FDA has accepted its resubmitted sNDA for Joenja in children ages 4 to 11 with APDS. The filing seeks approval for twice-daily dosing in pediatric patients weighing 27 kg or more, with a separate submission planned for lower-weight children later in 2026. The company included additional manufacturing batch testing data requested by the FDA, and the agency set a PDUFA date of October 24, 2026. If approved, Joenja would become the first U.S. treatment for younger children with APDS.

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