CRYSVITA (Kyowa Kirin Australia Pty Ltd)
Product name
CRYSVITA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
143 (255 working days)
Active ingredients
burosumab
Registration type
NCE/NBE
Indication
CRYSVITA (burosumab) (solution for injection) is indicated for the treatment of X-linked hypophosphataemia (XLH) in adults, adolescents and children 1 year of age or 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.