EU filing follows US progress for Pharming's leniolisib

Dutch rare disease specialist Pharming (Euronext: PHARM) has moved a step closer to marketing authorization for leniolisib in Europe.

Pharming has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the oral, selective phosphoinositide three-kinase delta inhibitor, as a treatment for activated phosphoinositide 3-kinase delta syndrome (APDS), a rare primary immunodeficiency, in adults and adolescents 12 years or older.

"Leniolisib has the potential to be the first approved treatment for this rare and orphan-designated disease"