EMA regulatory review of leniolisib for APDS pushed back

16 February 2023

Dutch rare disease specialist Pharming (Euronext: PHARM) has suffered a setback in the European approval process for its leniolisib, a treatment for activated phosphoinositide 3-kinase delta syndrome (APDS), a rare primary immunodeficiency.

It revealed that the European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) has decided to shift its assessment of the Marketing Authorization Application (MAA) for leniolisib to a standard review timetable.

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