27 September 2024 - The MHRA has on 25 September approved leniolisib phosphate (Joenja) to treat a rare immune disease known as activated phosphoinositide 3-kinase delta syndrome or APDS in adults and adolescents aged 12-years old and older who weigh 45 kg or more.

This is also the first time the MHRA has approved a new medicine following an approval by the US FDA. This is because the medicine was approved via a fast-track approval process for medicines, known as the International Recognition Procedure.

Read UK Government press release