CRYSVITA (burosumab) - Bone disease

Summary of opinion

Favourable opinion for reimbursement in:

• the treatment of X-linked hypophosphataemia, in children and adolescents aged 1 to 17 years with radiographic evidence of bone disease, and in adults.
• the treatment of FGF23-related hypophosphataemia in tumour-induced osteomalacia associated with phosphaturic mesenchymal tumours that cannot be curatively resected or localised in children and adolescents aged 1 to 17 years and in adults. 

No clinical added value of the new solution for injection in pre-filled syringe forms compared to the forms already available.