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CRYSVITA Kyowa Kirin Australia Pty Ltd
Product name
CRYSVITA
Sponsor
Accepted date
Jun-2025
Active ingredients
burosumab
Proposed indication
CRYSVITA (burosumab) is for the:
-treatment of X-linked hypophosphataemia (XLH), a genetic disorder characterized by low phosphate levels in the blood, leading to bone and teeth problems.
-treatment of hypophosphataemia that leads to bone softening as a result of mesenchymal tumours.
-treatment of X-linked hypophosphataemia (XLH), a genetic disorder characterized by low phosphate levels in the blood, leading to bone and teeth problems.
-treatment of hypophosphataemia that leads to bone softening as a result of mesenchymal tumours.
Application type
C (new indication)
Publication date
Jun-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.