EU approves Crysvita for FGF23-related hypophosphataemia in Tumour-Induced Osteomalacia
Kyowa Kirin announced that the European Commission (EC) approved Crysvita (burosumab) for the treatment of FGF23-related hypophosphataemia in Tumour-Induced Osteomalacia (TIO) associated with phosphaturic mesenchymal tumours (PMTs) that cannot be curatively resected or localised in children and adolescents aged 1 to 17 years and in adults
Crysvita is also already licensed in the EU for use in the rare disease X-Linked Hypophosphataemia (XLH), for children and adolescents between 1 and 17 years of age with radiographic evidence of bone disease, and in adults.
The efficacy and safety of Crysvita have been demonstrated in two Phase II clinical trials published in the disease area of TIO. Crysvita was well-tolerated and demonstrated an acceptable safety profile. With this approval by the European Commission, Crysvita is the first biologic treatment available to EU patients within its licensed indication for TIO. Crysvita blocks the action of fibroblast growth factor-23 (FGF23), which is produced in excess in TIO, restoring phosphate homeostasis.
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