Pharming Group provides updates on EMA regulatory review of leniolisib MAA and plans to file for UK regulatory approval

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. Resources For further information, please contact: Media Relations Investor Relations Quick links

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