MHRA approves Pharming’s Joenja® (leniolisib) as first treatment specifically for children with APDS in the U.K.

The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has approved an extension of Pharming's Joenja® (leniolisib) to treat children aged 4 to 11 years weighing at least 27kg with activated PI3K delta syndrome (APDS), a rare primary immunodeficiency. This marks the first treatment approved in the U.K. specifically for children with APDS, with availability expected in February 2027. The approval is supported by clinical data from Pharming's pediatric clinical program.