Kyowa Kirin Co., Ltd. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended that CRYSVITA® (burosumab) be approved 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 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. Also known as oncogenic osteomalacia, TIO is an acquired disorder caused by typically small, slow-growing, benign PMTs.

It is a rare condition with less than 1,000 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. A cure for TIO can be achieved with complete surgical resection of the causative tumour(s), however, surgical resection is not always possible due to the location and difficulty in detecting tumours.

TIO may recur and persist following incomplete or unsuccessful surgical resection.