Pharming receives positive EMA decision on paediatric investigation plan (PIP) for leniolisib in Europe
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).
"The approval of the PIP further supports our confidence in the potential of leniolisib to address this orphan disease and population and provides us with a pathway towards marketing approval in Europe, in parallel with our US regulatory strategy."- Anurag Relan - Chief Medical Officer