Pharming announces CHMP decision to shift leniolisib MAA to standard review

Pharming announced that the European Medicines Agency’s, or EMA, Committee for Human Medicinal Products, or CHMP, has decided to shift its assessment of the Marketing Authorization Application, or MAA, for leniolisib to a standard review timetable. Leniolisib is an oral selective phosphoinositide 3-kinase delta inhibitor under regulatory review as a treatment for activated phosphoinositide 3-kinase delta syndrome, a rare primary immunodeficiency, in adolescents and adults 12 years of age and older. Pharming has received the list of questions from EMA which included a request to submit updated data from the ongoing long-term extension study collected after the interim analysis included in the original MAA. Based on the timetable for our responses, Pharming expects that CHMP will issue its opinion on the leniolisib MAA in 2H 2023.