4 June 2026 - Pharming today announced that the US FDA has accepted its resubmitted supplemental new drug application seeking approval for Joenja (leniolisib), an oral, selective phosphoinositide 3-kinase delta inhibitor, as a treatment for children aged 4 to 11 years with activated phosphoinositide 3-kinase delta syndrome, a rare primary immunodeficiency. 

Following the Complete Response Letter received on 30 January 2026, and a subsequent Type A meeting with the FDA on 26 March 2026, the resubmission seeks approval of 40 mg and 50 mg twice daily dosing for paediatric patients weighing 27 kg or more, who represent a meaningful proportion of the identified paediatric patient population. 

The resubmission includes additional data requested by the FDA on analytical methods used for production batch testing. The FDA has assigned a PDUFA target action date of 24 October 2026.

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