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2022

Pharming receives agreement of Paediatric Investigation Plan and Promising Innovative Medicine designation for leniolisib from UK MHRA

Operational updates

An 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

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Pharming Announces Presentation of Positive Results of Phase III Leniolisib Trial in APDS at Clinical Immunology Society 2022 Annual Meeting

Conference attendance

Pharming announces that Principal Investigator V. Koneti Rao, MD, FRCPA, a staff physician in the Primary Immune Deficiency Clinic at the National Institutes of Health in Bethesda, Maryland, will present positive findings from the Phase III pivotal clinical trial of leniolisib for patients with activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) at the Clinical Immunology Society (CIS) 2022 Annual Meeting in Charlotte, North Carolina.

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