JOENJA Ballia Holdings Pty Ltd
Product name
JOENJA
Sponsor
Accepted date
Aug-2023
Active ingredients
leniolisib phosphate
Proposed indication
For the treatment of activated phosphoinositide 3-kinase delta syndrome (APDS) in adults and adolescents.
Application type
A (new medicine)
Publication date
Aug-2023
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.