|
Synonyms: burosumab-twza | Crysvita® | KRN-23 | KRN23 | N5KG1_C10_LH | UX-023 | UX023
burosumab is an approved drug (EMA & FDA (2018))
Compound class:
Antibody
Comment: Burosumab (KRN23) is a fully human anti-FGF-23 monoclonal antibody. Anti-FGF-23 mAbs are considered suitable for prevention or treatment of diseases which are caused by hyperactivity of FGF-23 or for diseases whose pathology might be improved by controlling FGF-23 activity [1,4].
Annotated peptide sequences for this antibody are available from its IMGT/mAb-DB record. BLAST peptide anaylsis reveals identical matches with peptides claimed in patent US7883705, with the claimed antibody being abbreviated to 'C10' in the document (full identifier N5KG1_C10_LH) [11]. |
| No information available. |
Summary of Clinical Use  |
| Burosumab was approved by the EMA in March 2018, and this was quickly followed by FDA approval in April of the same year [6]. Burosumab is approved as a treatment for X-linked hypophosphatemia [3,8]. |
| Mechanism Of Action and Pharmacodynamic Effects |
| X-linked hypophosphatemic (XLH) rickets is a rare disease that is caused by mutations in the PHEX gene (ORPHA:89936). Decreased expression of the PHEX-encoded endopeptidase leads to elevated serum FGF-23 (a phosphate-regulating hormone) levels and this reduces renal phosphate reabsorption [2,9-10]. The physiological outcome is hypophosphatemia which causes abnormal bone development and osteomalacia. Antibody-directed neutralisation of FGF-23 helps to restore phosphate levels in patients with XLH [5,7]. |
| Clinical Trials | |||||
| Clinical Trial ID | Title | Type | Source | Comment | References |
| NCT02526160 | Study of KRN23 in Adults With X-linked Hypophosphatemia (XLH) | Phase 3 Interventional | Ultragenyx Pharmaceutical Inc | ||
| External links |
|
For extended ADME data see the following: Electronic Medicines Compendium (eMC) Drugs.com European Medicines Agency (EMA) |
