Operational updates
Pharming Group announces approval of Joenja® (leniolisib) in Japan for the treatment of APDS in patients aged 4 years and older
Pharming Group N.V. today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Joenja® (leniolisib), an oral, selective phosphoinositide 3-kinase (PI3K) delta inhibitor, for the treatment of activated PI3K delta syndrome (APDS) in adult and pediatric patients aged 4 years and older.
- First approved treatment in Japan for activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS)
- Approval is based on positive Phase III data from multinational and Japanese studies in patients aged 12 years and older and a multinational pediatric study in children aged 4 to 11 years
- First approval of Joenja covering children aged 4 to 11 with APDS