Biopharmaceutical company Pharming Group N.V. (Euronext Amsterdam:PHARM) (NASDAQ:PHAR) announced on Thursday that Joenja (leniolisib) has received marketing authorisation in the UK for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and paediatric patients aged 12 years and older.

Leniolisib is the first approved treatment in the UK specifically for APDS, a rare and progressive primary immunodeficiency. It is currently under evaluation by the National Institute for Health and Care Excellence (NICE) regarding reimbursement within the National Health Service (NHS) in England.

The Medicines and Healthcare products Regulatory Agency (MHRA) evaluated the Marketing Authorisation Application (MAA) for leniolisib through the International Recognition Procedure (IRP) pathway on the basis of the US Food and Drug Administration (FDA) approval granted in March 2023.