Pharming receives positive EMA decision on paediatric investigation plan (PIP) for leniolisib in Europe

January 6, 2022 at 7:00 AM CET

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 (PIP) for leniolisib, a phosphoinositide 3-kinase (PI3K) inhibitor, currently in development for the treatment of activated phosphoinositide 3-kinase delta syndrome (APDS).