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Crysvita
Published
Product name
Crysvita
Active ingredient
Burosumab
Submission type
New biological entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Crysvita (burosumab) was approved for the following therapeutic use:
Crysvita (burosumab) is indicated for the treatment of X-linked hypophosphataemia (XLH) in adults, adolescents and children 1 year of age or older.
How this medicine works
Burosumab is a recombinant human monoclonal immunoglobulin G1 (IgG1) antibody that binds to and inhibits the biological activity of fibroblast growth factor 23 (FGF23), present in excess in X-linked hypophosphataemia. Neutralisation of FGF23 by burosumab increases renal tubular reabsorption of phosphate and the serum concentration of 1, 25 dihydroxy-vitamin D.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Crysvita was considered favourable for the therapeutic use approved.
Sponsor