Posted by Michael Wonder on 28 Sep 2022
Pharming announces US FDA acceptance for priority review of its new drug application for leniolisib
28 September 2022 - The FDA has assigned a PDUFA goal date of 29 March 2023 for the NDA submission based on randomised, controlled and long-term extension data for leniolisib as a treatment for APDS, a rare primary immunodeficiency.
Pharming announces that the US FDA has accepted for priority review its new drug application for leniolisib, an oral, selective phosphoinositide 3-kinase delta inhibitor, to treat the rare primary immunodeficiency activated phosphoinositide 3-kinase delta syndrome (APDS) in adults and adolescents 12 years of age and older in the US.
