CRYSVITA (Kyowa Kirin Australia Pty Ltd)
Product name
CRYSVITA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
103 (255 working days)
Active ingredients
burosumab
Registration type
EOI
Indication
CRYSVITA (burosumab) is indicated for the treatment of FGF23-related hypophosphataemia in tumour-induced osteomalacia associated with phosphaturic mesenchymal tumours that cannot be curatively resected or localised 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.