{"entity":{"id":"burosumab","kind":"drug","name":"Burosumab","aka":["burosumab","Crysvita","KRN23"],"tldr":"Crysvita is an antibody for a rare bone-softening condition in which the body leaks phosphate. Some small tumours cause it by making too much of a hormone called FGF23; when the tumour cannot be found or removed, Crysvita blocks the hormone.","summary":"Burosumab (Crysvita) has been authorised in the EU since 19 February 2018 (CHMP opinion 14 December 2017; marketing authorisation holder Kyowa Kirin Holdings B.V.; orphan designation) for X-linked hypophosphataemia in children and adolescents aged 1 to 17 with radiographic bone disease and in adults, and for FGF23-related hypophosphataemia in tumour-induced osteomalacia associated with phosphaturic mesenchymal tumours that cannot be curatively resected or localised. The cancer-care indication is the second: it treats the metabolic effect of a tumour rather than the tumour itself.","status":"approved","asOf":"2026-09-24","links":[{"label":"UX023T-CL201 (J Bone Miner Res 2021)","url":"https://doi.org/10.1002/jbmr.4233"},{"label":"EMA: Crysvita (EPAR)","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/crysvita"},{"label":"US label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=102f96a0-6e3a-4fc1-b204-34d604683af6"}],"tags":["ema-register","supportive"],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["kyowa-kirin"],"institutions":[],"pathways":[],"terms":[],"trials":["ux023t-cl201"],"people":[],"bottlenecks":[],"keyPapers":["paper-ux023t-cl201-jan-de-beur-jbmr-2021"],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo content wave 5 (EMA medicines register and EPAR pages)","editedOn":"2026-09-22"},"brand":"Crysvita","modality":"Monoclonal antibody (anti-FGF23)","supportive":true,"mechanism":"Antibody to fibroblast growth factor 23; used for FGF23-related hypophosphataemia, including the form caused by phosphate-wasting tumours (tumour-induced osteomalacia), where the tumour cannot be found or removed (indication wording, EMA).","approvals":[{"region":"EU","year":2018,"indication":"X-linked hypophosphataemia; FGF23-related hypophosphataemia in tumour-induced osteomalacia (phosphaturic mesenchymal tumours not curatively resectable or localisable)","note":"Authorised 19 Feb 2018; Kyowa Kirin"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/burosumab/","neighbours":{"company":[{"id":"kyowa-kirin","kind":"company","name":"Kyowa Kirin","route":"/companies/kyowa-kirin/"}],"trial":[{"id":"ux023t-cl201","kind":"trial","name":"UX023T-CL201","route":"/trials/ux023t-cl201/"}],"paper":[{"id":"paper-ux023t-cl201-jan-de-beur-jbmr-2021","kind":"paper","name":"Burosumab for the treatment of tumor-induced osteomalacia (UX023T-CL201)","route":"/key-papers/paper-ux023t-cl201-jan-de-beur-jbmr-2021/"}],"target":[{"id":"fgf23","kind":"target","name":"FGF23","route":"/targets/fgf23/"}]}}