JOENJA (Ballia Holdings Pty Ltd)
Product name
JOENJA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
129 (255 working days)
Active ingredients
leniolisib phosphate
Registration type
NCE/ NBE
Indication
JOENJA is indicated for the treatment of activated phosphoinositide 3-kinase delta syndrome (APDS) in adults and adolescents 12 years of age and older.
Registration process
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.