JOENJA Pharming Australia Pty Ltd
Product name
JOENJA
Sponsor
Accepted date
Dec-2025
Active ingredients
leniolisib phosphate
Proposed indication
JOENJA (leniolisib phosphate) is proposed for the treatment of activated phosphoinositide 3-kinase delta syndrome (APDS) in adults and children 4 years of age and older. APDS is due to a specific genetic change that over-activates part of the immune system, causing frequent infections, swollen lymph nodes or an enlarged spleen, autoimmune problems, and increasing the risk of developing lymphoma.
Application type
C (new indication)
Publication date
Dec-2025
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available.