Pharming receives positive EMA decision on paediatric investigation plan (PIP) for leniolisib in Europe
Pharming receives positive EMA decision on paediatric investigation plan (PIP) for leniolisib in Europe
January 6, 2022 at 7:00 AM CET
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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).