In the European Union and the United States, burosumab is indicated for the treatment of adults and children ages one year and older withX-linked hypophosphatemia (XLH), a rare, inherited form of rickets.[13] caused by overproduction of a hormone calledFGF23 (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-inducedosteomalacia (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]
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]
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]
^"International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 77".WHO Drug Information.31 (1). 2017.hdl:10665/330984.
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