Kyowa Kirin gains EC approval of Crysvita for TIO

Japanese drugmaker Kyowa Kirin (TYO: 4151) said on Friday that the European Commission (EC) has approved Crysvita (burosumab) for the treatment of FGF23-related hypophosphatemia in tumor-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors (PMTs) that cannot be curatively resected or localized in children and adolescents aged 1 to 17 years and in adults.

Crysvita is also already licensed in the European Union for use in the rare disease X-Linked hypophosphatemia (XLH), for children and adolescents aged between one and 17 years with radiographic evidence of bone disease, and in adults.

Also known as oncogenic osteomalacia, TIO is an acquired disorder caused by typically small, slow-growing, benign PMTs.  It is a rare condition with fewer than 1000 cases reported in the medical literature, which mainly affects adults and with a mean onset age of 40 – 45 years. TIO is associated with progressive and debilitating musculoskeletal deficits, ultimately having a detrimental impact on ability to perform daily activities, as well as on physical and social wellbeing.