Posted by Michael Wonder on 02 Oct 2025
Pharming Group announces US FDA acceptance and priority review of supplemental new drug application for leniolisib in children with APDS aged 4 to 11 years
1 October 2025 - Pharming today announced that the US FDA has accepted its supplemental new drug application seeking approval for 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.
The application has been granted priority review and assigned a PDUFA target action date of 31 January 2026.
