Pharming receives agreement of Paediatric Investigation Plan and Promising Innovative Medicine designation for leniolisib from UK MHRA
Operational updatesAn agreed Paediatric Investigation Plan (PIP) is the regulatory pathway to market authorization for leniolisib as a treatment for activated phosphoinositide 3-kinase delta syndrome (APDS) in children. A Promising Innovative Medicine (PIM) designation is an early indication that leniolisib is a candidate for the MHRA’s Early Access to Medicines Scheme