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 | |
| Pregnancy category | |
| Routes of administration | Subcutaneous |
| ATC code | |
| Legal status | |
| Legal status | |
| Pharmacokinetic data | |
| Elimination half-life | 16.4 days[10] |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| ChemSpider |
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| UNII | |
| KEGG | |
| E number | {{#property:P628}} |
| CompTox Dashboard (EPA) |
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| ECHA InfoCard | {{#property:P2566}}Lua error in Module:EditAtWikidata at line 29: attempt to index field 'wikibase' (a nil value). |
| 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]
Medical uses
[edit | edit source]In the European Union and the United States, burosumab is indicated for the treatment of adults and children ages one year and older with X-linked hypophosphatemia (XLH), a rare, inherited form of rickets.[13] caused by overproduction of a hormone called FGF23 (fibroblast growth factor 23) in bone cells. FGF23 is responsible for blocking phosphate re-absorption in the kidney and the suppression of the vitamin D dependent phosphate absorption in the intestine. Due to the excess activity of FGF23, phosphate levels in the blood are abnormally low (hypophosphatemia), which affects the constitution of bone.[14]
In the United States, burosumab is also approved to treat people age two and older with tumor-induced osteomalacia (TIO), a rare disease which is characterized by the development of tumors causing weakened and softened bones.[15] The tumors associated with TIO release fibroblast growth factor 23 (FGF23) which lowers phosphate levels.[15]
Adverse effects
[edit | edit source]In trials, injection site reactions were very common, occurring in 52–58% of patients; they were generally mild in severity, and resolved on their own in 1–3 days.[16]
Legal status
[edit | edit source]It was approved for use in the European Union in February 2018 to treat children one year of age and older and adolescents with growing skeletons who have X-linked hypophosphataemia with radiographic evidence of bone disease .[17]
In April 2018, the U.S. Food and Drug Administration (FDA) approved burosumab for its intended purpose in patients aged one year and older.[13] The FDA approval fell under both the breakthrough therapy and orphan drug designations.[13][18] The FDA considered it to be a first-in-class medication.[19]
In 2018, the National Institute for Health and Care Excellence in England and Wales raised concerns regarding the incremental cost-effectiveness of the new treatment[20] but as of 2019 the drug was available through a simple discount scheme.[21]
History
[edit | edit source]This drug was developed by Ultragenyx and is in a collaborative license agreement with Kyowa Hakko Kirin.[22]
References
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This article incorporates text from this source, which is in the public domain.
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- ^ a b Lua error in Module:Citation/CS1/Configuration at line 2172: attempt to index field '?' (a nil value). This article incorporates text from this source, which is in the public domain.
- ^ FDA Professional Drug Information
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External links
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