Pharming Group announces positive results from the pivotal Phase II/III blinded randomized, placebo-controlled registration-enabling study of leniolisib for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) also known as PASLI (p110δ-activating mutation causing
An agreed PIP is the regulatory pathway to market authorization for leniolisib as a treatment of activated phosphoinositide 3-kinase delta syndrome in children. Pharming announces that a positive decision has been made by the European Medicines Agency (EMA) on the Paediatric Investigation Plan