Monoclonal antibody designed to treat X-linked hypophosphatemia
Burosumab
Monoclonal antibody
Type
Whole antibody
Source
Human
Target
FGF 23
Clinical data
Pronunciation
bur OH sue mab
Trade names
Crysvita
Other names
KRN-23, KRN23, burosumab-twza
AHFS/Drugs.com
Monograph
MedlinePlus
a618034
License data
EU EMA: by INN
US DailyMed: Burosumab
Pregnancy category
AU: B3[1][2]
Routes of administration
Subcutaneous
ATC code
M05BX05 (WHO)
Legal status
Legal status
AU: S4 (Prescription only)[1][3][4]
CA: ℞-only / Schedule D[5][6]
UK: POM (Prescription only)[7]
US: ℞-only[8][9]
EU: Rx-only
In general: ℞ (Prescription only)
Pharmacokinetic data
Elimination half-life
16.4 days[10]
Identifiers
CAS Number
1610833-03-8
DrugBank
DB14012
ChemSpider
none
UNII
G9WJT6RD29
KEGG
D10913
Chemical and physical data
Formula
C6388H9904N1700O2006S46
Molar mass
144090.15 g·mol−1
Burosumab, sold under the brand name Crysvita, is a human monoclonal antibody medication approved 2018 for the treatment of X-linked hypophosphatemia and tumor-induced osteomalacia.[8][11][12]
^ ab"Crysvita". Therapeutic Goods Administration (TGA). 17 September 2021. Retrieved 17 September 2021.
^"Updates to the Prescribing Medicines in Pregnancy database". Therapeutic Goods Administration (TGA). 12 May 2022. Retrieved 13 May 2022.
^"Crysvita burosumab 10 mg/mL solution for injection in a 5 mL vial". Therapeutic Goods Administration (TGA). Archived from the original on 17 September 2021. Retrieved 17 September 2021.
^"Crysvita burosumab 10 mg/mL solution for injection in a 5 mL vial". Therapeutic Goods Administration (TGA). Archived from the original (PDF) on 17 September 2021. Retrieved 17 September 2021.
^"Crysvita Product information". Health Canada. 25 April 2012. Retrieved 29 May 2022.
^"Summary Basis of Decision (SBD) for Crysvita". Health Canada. 23 October 2014. Retrieved 29 May 2022.
^"Crysvita 10 mg solution for injection - Summary of Product Characteristics (SmPC)". (emc). 20 April 2020. Retrieved 19 June 2020.
^ ab"Crysvita- burosumab injection". DailyMed. Retrieved 17 September 2021.
^"Drug Approval Package: Crysvita (burosumab-twza)". U.S. Food and Drug Administration (FDA). 15 May 2018. Retrieved 28 February 2020.
^Zhang X, Imel EA, Ruppe MD, Weber TJ, Klausner MA, Ito T, et al. (February 2016). "Pharmacokinetics and pharmacodynamics of a human monoclonal anti-FGF23 antibody (KRN23) in the first multiple ascending-dose trial treating adults with X-linked hypophosphatemia". Journal of Clinical Pharmacology. 56 (2): 176–85. doi:10.1002/jcph.570. PMC 5042055. PMID 26073451.
^World Health Organization (2017). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 77". WHO Drug Information. 31 (1). hdl:10665/330984.
^"Burosumab (KRN23) for X-Linked Hypophosphatemia (XLH)" (PDF). n.d. Archived from the original (PDF) on 18 April 2018. Retrieved 18 April 2018.
Burosumab, sold under the brand name Crysvita, is a human monoclonal antibody medication approved 2018 for the treatment of X-linked hypophosphatemia...
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hypophosphataemia treated with a human monoclonal antibody against FGF23 called burosumab improved significantly compared to conventional therapy. Online Mendelian...
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