Pharming Group provides updates on EMA regulatory review of leniolisib MAA and plans to file for UK regulatory approval
Pharming Group N.V. announces that it has received a Day 180 Second List of Outstanding Issues (LoOI) from the European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) regarding its Marketing Authorisation Application (MAA) for leniolisib for adult and pediatric patients 12 years of age and older with APDS, a rare primary immunodeficiency. Based on the timetable included in the CHMP Day 180 Second LoOI, and considering the CHMP’s decision to reschedule the Ad-Hoc Expert Group (AEG) meeting to the end of November, Pharming now expects the CHMP to issue its opinion on the leniolisib MAA in the first quarter of 2024.
Pharming now intends to file an MAA with the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) through the International Recognition Procedure (IRP) which will replace the European Commission Decision Recognition Procedure (ECDRP) from January 1, 2024. Under the IRP, Pharming would file an MAA for leniolisib on the basis of the US FDA approval in the first quarter of 2024 and the MHRA would have 110 days from the date the IRP submission is validated to review and issue its decision.