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dir="ltr"><div class="shortdescription nomobile noexcerpt noprint searchaux" style="display:none">Monoclonal antibody designed to treat X-linked hypophosphatemia</div> <p class="mw-empty-elt"> </p> <style data-mw-deduplicate="TemplateStyles:r1257001546">.mw-parser-output .infobox-subbox{padding:0;border:none;margin:-3px;width:auto;min-width:100%;font-size:100%;clear:none;float:none;background-color:transparent}.mw-parser-output .infobox-3cols-child{margin:auto}.mw-parser-output .infobox .navbar{font-size:100%}@media screen{html.skin-theme-clientpref-night .mw-parser-output .infobox-full-data:not(.notheme)>div:not(.notheme)[style]{background:#1f1f23!important;color:#f8f9fa}}@media screen and (prefers-color-scheme:dark){html.skin-theme-clientpref-os .mw-parser-output .infobox-full-data:not(.notheme) div:not(.notheme){background:#1f1f23!important;color:#f8f9fa}}@media(min-width:640px){body.skin--responsive .mw-parser-output .infobox-table{display:table!important}body.skin--responsive .mw-parser-output .infobox-table>caption{display:table-caption!important}body.skin--responsive .mw-parser-output .infobox-table>tbody{display:table-row-group}body.skin--responsive .mw-parser-output .infobox-table tr{display:table-row!important}body.skin--responsive .mw-parser-output .infobox-table th,body.skin--responsive .mw-parser-output .infobox-table td{padding-left:inherit;padding-right:inherit}}</style><table class="infobox" style="border-spacing:2px;"><caption class="infobox-title"><span title="International nonproprietary name (INN): Burosumab">Burosumab</span></caption><tbody><tr><th colspan="2" class="infobox-header" style="background:#ddd"><a href="/wiki/Monoclonal_antibody" title="Monoclonal antibody">Monoclonal antibody</a></th></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/File:Engineered_monoclonal_antibodies.svg" title="File:Engineered monoclonal antibodies.svg">Type</a></th><td class="infobox-data">Whole antibody</td></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/Monoclonal_antibody#Production" title="Monoclonal antibody">Source</a></th><td class="infobox-data"><a href="/wiki/Human" title="Human">Human</a></td></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/Antigen" title="Antigen">Target</a></th><td class="infobox-data"><a href="/wiki/Fibroblast_growth_factor_23" title="Fibroblast growth factor 23">FGF 23</a></td></tr><tr><th colspan="2" class="infobox-header" style="background:#ddd">Clinical data</th></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;">Pronunciation</th><td class="infobox-data">bur OH sue mab </td></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/Drug_nomenclature#Trade_names" title="Drug nomenclature">Trade names</a></th><td class="infobox-data">Crysvita</td></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;">Other names</th><td class="infobox-data">KRN-23, KRN23, burosumab-twza</td></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/American_Society_of_Health-System_Pharmacists" title="American Society of Health-System Pharmacists">AHFS</a>/<a href="/wiki/Drugs.com" title="Drugs.com">Drugs.com</a></th><td class="infobox-data"><span title="www.drugs.com"><a rel="nofollow" class="external text" href="https://www.drugs.com/monograph/burosumab-twza.html">Monograph</a></span></td></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/MedlinePlus" title="MedlinePlus">MedlinePlus</a></th><td class="infobox-data"><span title="medlineplus.gov"><a rel="nofollow" class="external text" href="https://medlineplus.gov/druginfo/meds/a618034.html">a618034</a></span></td></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/Regulation_of_therapeutic_goods" title="Regulation of therapeutic goods">License data</a></th><td class="infobox-data"><style data-mw-deduplicate="TemplateStyles:r1126788409">.mw-parser-output .plainlist ol,.mw-parser-output .plainlist ul{line-height:inherit;list-style:none;margin:0;padding:0}.mw-parser-output .plainlist ol li,.mw-parser-output .plainlist ul li{margin-bottom:0}</style><div class="plainlist"> <ul><li><small><abbr class="country-name" title="European Union">EU</abbr></small> <a href="/wiki/European_Medicines_Agency" title="European Medicines Agency">EMA</a>: <span title="www.ema.europa.eu: 'Burosumab'"><a rel="nofollow" class="external text" href="https://www.ema.europa.eu/en/medicines/search_api_aggregation_ema_active_substance_and_inn_common_name/Burosumab">by INN</a></span></li> <li><small><abbr class="country-name" title="United States">US</abbr></small> <a href="/wiki/DailyMed" title="DailyMed">DailyMed</a>: <span title="dailymed.nlm.nih.gov"><a rel="nofollow" class="external text" href="https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Burosumab">Burosumab</a></span></li></ul></div> </td></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/Pregnancy_category" title="Pregnancy category">Pregnancy<br />category</a></th><td class="infobox-data"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1126788409"><div class="plainlist"> <ul><li><small><abbr class="country-name" title="Australia">AU</abbr>:</small> B3<sup id="cite_ref-Crysvita_APM_summary_1-0" class="reference"><a href="#cite_note-Crysvita_APM_summary-1"><span class="cite-bracket">[</span>1<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-2" class="reference"><a href="#cite_note-2"><span class="cite-bracket">[</span>2<span class="cite-bracket">]</span></a></sup></li> <li class="mw-empty-elt"></li></ul> </div></td></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/Route_of_administration" title="Route of administration">Routes of<br />administration</a></th><td class="infobox-data"><a href="/wiki/Subcutaneous_injection" class="mw-redirect" title="Subcutaneous injection">Subcutaneous</a></td></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/Anatomical_Therapeutic_Chemical_Classification_System" title="Anatomical Therapeutic Chemical Classification System">ATC code</a></th><td class="infobox-data"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1126788409"><div class="plainlist"><ul><li><a href="/wiki/ATC_code_M05" title="ATC code M05">M05BX05</a> (<span title="www.whocc.no"><a rel="nofollow" class="external text" href="https://www.whocc.no/atc_ddd_index/?code=M05BX05">WHO</a></span>) </li></ul></div></td></tr><tr><th colspan="2" class="infobox-header" style="background:#ddd">Legal status</th></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/Regulation_of_therapeutic_goods" title="Regulation of therapeutic goods">Legal status</a></th><td class="infobox-data"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1126788409"><div class="plainlist"> <ul><li><small><abbr class="country-name" title="Australia">AU</abbr>:</small> <a href="/wiki/Standard_for_the_Uniform_Scheduling_of_Medicines_and_Poisons#Schedule_4" title="Standard for the Uniform Scheduling of Medicines and Poisons">S4</a> (Prescription only)<sup id="cite_ref-Crysvita_APM_summary_1-1" class="reference"><a href="#cite_note-Crysvita_APM_summary-1"><span class="cite-bracket">[</span>1<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-3" class="reference"><a href="#cite_note-3"><span class="cite-bracket">[</span>3<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-4" class="reference"><a href="#cite_note-4"><span class="cite-bracket">[</span>4<span class="cite-bracket">]</span></a></sup></li> <li><small><abbr class="country-name" title="Canada">CA</abbr></small>: <a href="/wiki/Prescription_drug" title="Prescription drug"> ℞-only</a> / Schedule D<sup id="cite_ref-5" class="reference"><a href="#cite_note-5"><span class="cite-bracket">[</span>5<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-6" class="reference"><a href="#cite_note-6"><span class="cite-bracket">[</span>6<span class="cite-bracket">]</span></a></sup></li> <li><small><abbr class="country-name" title="United Kingdom">UK</abbr>:</small> <a href="/wiki/Prescription_drug" title="Prescription drug">POM</a> (Prescription only)<sup id="cite_ref-7" class="reference"><a href="#cite_note-7"><span class="cite-bracket">[</span>7<span class="cite-bracket">]</span></a></sup></li> <li><small><abbr class="country-name" title="United States">US</abbr>:</small> <a href="/wiki/Prescription_drug" title="Prescription drug">℞-only</a><sup id="cite_ref-Crysvita_FDA_label_8-0" class="reference"><a href="#cite_note-Crysvita_FDA_label-8"><span class="cite-bracket">[</span>8<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-9" class="reference"><a href="#cite_note-9"><span class="cite-bracket">[</span>9<span class="cite-bracket">]</span></a></sup></li> <li><small><abbr class="country-name" title="European Union">EU</abbr>:</small> Rx-only</li> <li>In general: ℞ (Prescription only)</li></ul></div> </td></tr><tr><th colspan="2" class="infobox-header" style="background:#ddd"><a href="/wiki/Pharmacokinetics" title="Pharmacokinetics">Pharmacokinetic</a> data</th></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/Biological_half-life" title="Biological half-life">Elimination <span class="nowrap">half-life</span></a></th><td class="infobox-data">16.4 days<sup id="cite_ref-10" class="reference"><a href="#cite_note-10"><span class="cite-bracket">[</span>10<span class="cite-bracket">]</span></a></sup></td></tr><tr><th colspan="2" class="infobox-header" style="background:#ddd">Identifiers</th></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/CAS_Registry_Number" title="CAS Registry Number">CAS Number</a></th><td class="infobox-data"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1126788409"><div class="plainlist"><ul><li><span title="commonchemistry.cas.org"><a rel="nofollow" class="external text" href="https://commonchemistry.cas.org/detail?cas_rn=1610833-03-8">1610833-03-8</a></span></li></ul></div></td></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/DrugBank" title="DrugBank">DrugBank</a></th><td class="infobox-data"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1126788409"><div class="plainlist"><ul><li><span title="www.drugbank.ca"><a rel="nofollow" class="external text" href="https://www.drugbank.ca/drugs/DB14012">DB14012</a></span></li></ul></div></td></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/ChemSpider" title="ChemSpider">ChemSpider</a></th><td class="infobox-data"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1126788409"><div class="plainlist"><ul><li>none</li></ul></div></td></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/Unique_Ingredient_Identifier" title="Unique Ingredient Identifier">UNII</a></th><td class="infobox-data"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1126788409"><div class="plainlist"><ul><li><span title="precision.fda.gov"><a rel="nofollow" class="external text" href="https://precision.fda.gov/uniisearch/srs/unii/G9WJT6RD29">G9WJT6RD29</a></span></li></ul></div></td></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/KEGG" title="KEGG">KEGG</a></th><td class="infobox-data"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1126788409"><div class="plainlist"><ul><li><span title="www.kegg.jp"><a rel="nofollow" class="external text" href="https://www.kegg.jp/entry/D10913">D10913</a></span></li></ul></div></td></tr><tr><th colspan="2" class="infobox-header" style="background:#ddd">Chemical and physical data</th></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/Chemical_formula" title="Chemical formula">Formula</a></th><td class="infobox-data"><span title="Carbon">C</span><sub>6388</sub><span title="Hydrogen">H</span><sub>9904</sub><span title="Nitrogen">N</span><sub>1700</sub><span title="Oxygen">O</span><sub>2006</sub><span title="Sulfur">S</span><sub>46</sub></td></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/Molar_mass" title="Molar mass">Molar mass</a></th><td class="infobox-data"><span class="nowrap"><span data-sort-value="7005144090150000000♠"></span>144<span style="margin-left:.25em;">090</span>.15</span> g·mol<sup>−1</sup></td></tr></tbody></table> <p><b>Burosumab</b>, sold under the brand name <b>Crysvita</b>, is a <a href="/wiki/Human_monoclonal_antibody" class="mw-redirect" title="Human monoclonal antibody">human monoclonal antibody</a> medication approved 2018 for the treatment of <a href="/wiki/X-linked_hypophosphatemia" title="X-linked hypophosphatemia">X-linked hypophosphatemia</a> and tumor-induced osteomalacia.<sup id="cite_ref-Crysvita_FDA_label_8-1" class="reference"><a href="#cite_note-Crysvita_FDA_label-8"><span class="cite-bracket">[</span>8<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-11" class="reference"><a href="#cite_note-11"><span class="cite-bracket">[</span>11<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-Slidebackground_12-0" class="reference"><a href="#cite_note-Slidebackground-12"><span class="cite-bracket">[</span>12<span class="cite-bracket">]</span></a></sup> </p> <meta property="mw:PageProp/toc" /> <div class="mw-heading mw-heading2"><h2 id="Medical_uses">Medical uses</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Burosumab&action=edit&section=1" title="Edit section: Medical uses"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>In the European Union and the United States, burosumab is indicated for the treatment of adults and children ages one year and older with <a href="/wiki/X-linked_hypophosphatemia" title="X-linked hypophosphatemia">X-linked hypophosphatemia</a> (XLH), a rare, inherited form of rickets.<sup id="cite_ref-FDA_PR_20180417_13-0" class="reference"><a href="#cite_note-FDA_PR_20180417-13"><span class="cite-bracket">[</span>13<span class="cite-bracket">]</span></a></sup> caused by overproduction of a hormone called <a href="/wiki/FGF23" class="mw-redirect" title="FGF23">FGF23</a> (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 (<a href="/wiki/Hypophosphatemia" title="Hypophosphatemia">hypophosphatemia</a>), which affects the constitution of bone.<sup id="cite_ref-14" class="reference"><a href="#cite_note-14"><span class="cite-bracket">[</span>14<span class="cite-bracket">]</span></a></sup> </p><p>In the United States, burosumab is also approved to treat people age two and older with tumor-induced <a href="/wiki/Osteomalacia" title="Osteomalacia">osteomalacia</a> (TIO), a rare disease which is characterized by the development of tumors causing weakened and softened bones.<sup id="cite_ref-FDA_PR_20200618_15-0" class="reference"><a href="#cite_note-FDA_PR_20200618-15"><span class="cite-bracket">[</span>15<span class="cite-bracket">]</span></a></sup> The tumors associated with TIO release fibroblast growth factor 23 (FGF23) which lowers phosphate levels.<sup id="cite_ref-FDA_PR_20200618_15-1" class="reference"><a href="#cite_note-FDA_PR_20200618-15"><span class="cite-bracket">[</span>15<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading2"><h2 id="Adverse_effects">Adverse effects</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Burosumab&action=edit&section=2" title="Edit section: Adverse effects"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>In trials, <a href="/wiki/Injection_site_reaction" title="Injection site reaction">injection site reactions</a> were very common, occurring in 52–58% of patients; they were generally mild in severity, and resolved on their own in 1–3 days.<sup id="cite_ref-16" class="reference"><a href="#cite_note-16"><span class="cite-bracket">[</span>16<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading2"><h2 id="Legal_status">Legal status</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Burosumab&action=edit&section=3" title="Edit section: Legal status"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>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 .<sup id="cite_ref-Crysvita_EPAR_17-0" class="reference"><a href="#cite_note-Crysvita_EPAR-17"><span class="cite-bracket">[</span>17<span class="cite-bracket">]</span></a></sup> </p><p>In April 2018, the U.S. <a href="/wiki/Food_and_Drug_Administration" title="Food and Drug Administration">Food and Drug Administration</a> (FDA) approved burosumab for its intended purpose in patients aged one year and older.<sup id="cite_ref-FDA_PR_20180417_13-1" class="reference"><a href="#cite_note-FDA_PR_20180417-13"><span class="cite-bracket">[</span>13<span class="cite-bracket">]</span></a></sup> The FDA approval fell under both the <a href="/wiki/Breakthrough_therapy" title="Breakthrough therapy">breakthrough therapy</a> and <a href="/wiki/Orphan_drug#United_States" title="Orphan drug">orphan drug</a> designations.<sup id="cite_ref-FDA_PR_20180417_13-2" class="reference"><a href="#cite_note-FDA_PR_20180417-13"><span class="cite-bracket">[</span>13<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-18" class="reference"><a href="#cite_note-18"><span class="cite-bracket">[</span>18<span class="cite-bracket">]</span></a></sup> The FDA considered it to be a <a href="/wiki/First-in-class_medication" title="First-in-class medication">first-in-class medication</a>.<sup id="cite_ref-19" class="reference"><a href="#cite_note-19"><span class="cite-bracket">[</span>19<span class="cite-bracket">]</span></a></sup> </p><p>In 2018, the <a href="/wiki/National_Institute_for_Health_and_Care_Excellence" title="National Institute for Health and Care Excellence">National Institute for Health and Care Excellence</a> in England and Wales raised concerns regarding the incremental <a href="/wiki/Cost-effectiveness" class="mw-redirect" title="Cost-effectiveness">cost-effectiveness</a> of the new treatment<sup id="cite_ref-20" class="reference"><a href="#cite_note-20"><span class="cite-bracket">[</span>20<span class="cite-bracket">]</span></a></sup> but as of 2019 the drug was available through a simple discount scheme.<sup id="cite_ref-21" class="reference"><a href="#cite_note-21"><span class="cite-bracket">[</span>21<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading2"><h2 id="History">History</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Burosumab&action=edit&section=4" title="Edit section: History"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>This drug was developed by Ultragenyx and is in a collaborative license agreement with Kyowa Hakko Kirin.<sup id="cite_ref-22" class="reference"><a href="#cite_note-22"><span class="cite-bracket">[</span>22<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading2"><h2 id="References">References</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Burosumab&action=edit&section=5" title="Edit section: References"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <style data-mw-deduplicate="TemplateStyles:r1239543626">.mw-parser-output .reflist{margin-bottom:0.5em;list-style-type:decimal}@media screen{.mw-parser-output .reflist{font-size:90%}}.mw-parser-output .reflist .references{font-size:100%;margin-bottom:0;list-style-type:inherit}.mw-parser-output .reflist-columns-2{column-width:30em}.mw-parser-output .reflist-columns-3{column-width:25em}.mw-parser-output .reflist-columns{margin-top:0.3em}.mw-parser-output .reflist-columns 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q{quotes:"\"""\"""'""'"}.mw-parser-output .citation:target{background-color:rgba(0,127,255,0.133)}.mw-parser-output .id-lock-free.id-lock-free a{background:url("//upload.wikimedia.org/wikipedia/commons/6/65/Lock-green.svg")right 0.1em center/9px no-repeat}.mw-parser-output .id-lock-limited.id-lock-limited a,.mw-parser-output .id-lock-registration.id-lock-registration a{background:url("//upload.wikimedia.org/wikipedia/commons/d/d6/Lock-gray-alt-2.svg")right 0.1em center/9px no-repeat}.mw-parser-output .id-lock-subscription.id-lock-subscription a{background:url("//upload.wikimedia.org/wikipedia/commons/a/aa/Lock-red-alt-2.svg")right 0.1em center/9px no-repeat}.mw-parser-output .cs1-ws-icon a{background:url("//upload.wikimedia.org/wikipedia/commons/4/4c/Wikisource-logo.svg")right 0.1em center/12px no-repeat}body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .id-lock-free a,body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .id-lock-limited a,body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .id-lock-registration a,body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .id-lock-subscription a,body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .cs1-ws-icon a{background-size:contain;padding:0 1em 0 0}.mw-parser-output .cs1-code{color:inherit;background:inherit;border:none;padding:inherit}.mw-parser-output .cs1-hidden-error{display:none;color:var(--color-error,#d33)}.mw-parser-output .cs1-visible-error{color:var(--color-error,#d33)}.mw-parser-output .cs1-maint{display:none;color:#085;margin-left:0.3em}.mw-parser-output .cs1-kern-left{padding-left:0.2em}.mw-parser-output .cs1-kern-right{padding-right:0.2em}.mw-parser-output .citation .mw-selflink{font-weight:inherit}@media screen{.mw-parser-output .cs1-format{font-size:95%}html.skin-theme-clientpref-night .mw-parser-output .cs1-maint{color:#18911f}}@media screen and (prefers-color-scheme:dark){html.skin-theme-clientpref-os .mw-parser-output .cs1-maint{color:#18911f}}</style><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://www.tga.gov.au/apm-summary/crysvita">"Crysvita"</a>. <i>Therapeutic Goods Administration (TGA)</i>. 17 September 2021<span class="reference-accessdate">. Retrieved <span class="nowrap">17 September</span> 2021</span>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=unknown&rft.jtitle=Therapeutic+Goods+Administration+%28TGA%29&rft.atitle=Crysvita&rft.date=2021-09-17&rft_id=https%3A%2F%2Fwww.tga.gov.au%2Fapm-summary%2Fcrysvita&rfr_id=info%3Asid%2Fen.wikipedia.org%3ABurosumab" class="Z3988"></span></span> </li> <li id="cite_note-2"><span class="mw-cite-backlink"><b><a href="#cite_ref-2">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://www.tga.gov.au/resources/resource/guidance/updates-prescribing-medicines-pregnancy-database">"Updates to the Prescribing Medicines in Pregnancy database"</a>. <i>Therapeutic Goods Administration (TGA)</i>. 12 May 2022<span class="reference-accessdate">. Retrieved <span class="nowrap">13 May</span> 2022</span>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=unknown&rft.jtitle=Therapeutic+Goods+Administration+%28TGA%29&rft.atitle=Updates+to+the+Prescribing+Medicines+in+Pregnancy+database&rft.date=2022-05-12&rft_id=https%3A%2F%2Fwww.tga.gov.au%2Fresources%2Fresource%2Fguidance%2Fupdates-prescribing-medicines-pregnancy-database&rfr_id=info%3Asid%2Fen.wikipedia.org%3ABurosumab" class="Z3988"></span></span> </li> <li id="cite_note-3"><span class="mw-cite-backlink"><b><a href="#cite_ref-3">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://web.archive.org/web/20210917193625/https://tga-search.clients.funnelback.com/s/search.html?collection=tga-artg&profile=record&meta_i=340793">"Crysvita burosumab 10 mg/mL solution for injection in a 5 mL vial"</a>. <i>Therapeutic Goods Administration (TGA)</i>. 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Retrieved <span class="nowrap">17 September</span> 2021</span>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=unknown&rft.jtitle=Therapeutic+Goods+Administration+%28TGA%29&rft.atitle=Crysvita+burosumab+10+mg%2FmL+solution+for+injection+in+a+5+mL+vial&rft_id=https%3A%2F%2Ftga-search.clients.funnelback.com%2Fs%2Fsearch.html%3Fcollection%3Dtga-artg%26profile%3Drecord%26meta_i%3D340793&rfr_id=info%3Asid%2Fen.wikipedia.org%3ABurosumab" class="Z3988"></span></span> </li> <li id="cite_note-4"><span class="mw-cite-backlink"><b><a href="#cite_ref-4">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://web.archive.org/web/20210917193625/https://tga-search.clients.funnelback.com/s/search.html?collection=tga-artg&profile=record&meta_i=340793">"Crysvita burosumab 10 mg/mL solution for injection in a 5 mL vial"</a>. <i>Therapeutic Goods Administration (TGA)</i>. 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Retrieved <span class="nowrap">17 September</span> 2021</span>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=unknown&rft.jtitle=Therapeutic+Goods+Administration+%28TGA%29&rft.atitle=Crysvita+burosumab+10+mg%2FmL+solution+for+injection+in+a+5+mL+vial&rft_id=https%3A%2F%2Ftga-search.clients.funnelback.com%2Fs%2Fsearch.html%3Fcollection%3Dtga-artg%26profile%3Drecord%26meta_i%3D340793&rfr_id=info%3Asid%2Fen.wikipedia.org%3ABurosumab" class="Z3988"></span></span> </li> <li id="cite_note-5"><span class="mw-cite-backlink"><b><a href="#cite_ref-5">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://health-products.canada.ca/dpd-bdpp/info.do?lang=en&code=97399">"Crysvita Product information"</a>. <i>Health Canada</i>. 25 April 2012<span class="reference-accessdate">. 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Retrieved <span class="nowrap">14 June</span> 2019</span>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=unknown&rft.jtitle=www.nice.org.uk&rft.atitle=1+Recommendations+%7C+Burosumab+for+treating+X-linked+hypophosphataemia+in+children+and+young+people.+Guidance+NICE&rft_id=https%3A%2F%2Fwww.nice.org.uk%2Fguidance%2Fhst8%2Fchapter%2F1-Recommendations&rfr_id=info%3Asid%2Fen.wikipedia.org%3ABurosumab" class="Z3988"></span></span> </li> <li id="cite_note-22"><span class="mw-cite-backlink"><b><a href="#cite_ref-22">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite class="citation pressrelease cs1"><a rel="nofollow" class="external text" href="http://www.kyowa-kirin.com/news_releases/2013/e20130904_01.html">"Collaboration with Ultragenyx to Develop and Commercialize KRN23 for X-linked Hypophosphatemia"</a> (Press release). Kyowa Kirin. 4 September 2013<span class="reference-accessdate">. Retrieved <span class="nowrap">17 April</span> 2018</span>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=unknown&rft.btitle=Collaboration+with+Ultragenyx+to+Develop+and+Commercialize+KRN23+for+X-linked+Hypophosphatemia&rft.pub=Kyowa+Kirin&rft.date=2013-09-04&rft_id=http%3A%2F%2Fwww.kyowa-kirin.com%2Fnews_releases%2F2013%2Fe20130904_01.html&rfr_id=info%3Asid%2Fen.wikipedia.org%3ABurosumab" class="Z3988"></span></span> </li> </ol></div></div> <div class="mw-heading mw-heading2"><h2 id="External_links">External links</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Burosumab&action=edit&section=6" title="Edit section: External links"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <ul><li><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://druginfo.nlm.nih.gov/drugportal/name/burosumab">"Burosumab"</a>. <i>Drug Information Portal</i>. 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navbox-list navbox-odd hlist" style="width:100%;padding:0"><div style="padding:0 0.25em"></div><table class="nowraplinks navbox-subgroup" style="border-spacing:0"><tbody><tr><th scope="row" class="navbox-group" style="width:1%">Human</th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a class="mw-selflink selflink">Burosumab</a></li> <li><a href="/wiki/Denosumab" title="Denosumab">Denosumab</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%">Humanized</th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Blosozumab" title="Blosozumab">Blosozumab</a><sup>†</sup></li> <li><a href="/wiki/Romosozumab" title="Romosozumab">Romosozumab</a></li></ul> </div></td></tr></tbody></table><div></div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%"><a 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scope="row" class="navbox-group" style="width:1%">Human</th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Abelacimab" title="Abelacimab">Abelacimab</a></li> <li><a href="/wiki/Alirocumab" title="Alirocumab">Alirocumab</a></li> <li><a href="/wiki/Ascrinvacumab" title="Ascrinvacumab">Ascrinvacumab</a><sup>§</sup></li> <li><a href="/wiki/Bentracimab" title="Bentracimab">Bentracimab</a><sup>†</sup></li> <li><a href="/wiki/Enoticumab" title="Enoticumab">Enoticumab</a></li> <li><a href="/wiki/Evinacumab" title="Evinacumab">Evinacumab</a></li> <li><a href="/wiki/Evolocumab" title="Evolocumab">Evolocumab</a></li> <li><a href="/wiki/Icrucumab" title="Icrucumab">Icrucumab</a></li> <li><a href="/wiki/Inclacumab" title="Inclacumab">Inclacumab</a></li> <li><a href="/wiki/Marstacimab" title="Marstacimab">Marstacimab</a></li> <li><a href="/wiki/Nesvacumab" title="Nesvacumab">Nesvacumab</a></li> <li><a href="/wiki/Orticumab" title="Orticumab">Orticumab</a></li> <li><a href="/wiki/Ramucirumab" title="Ramucirumab">Ramucirumab</a></li> <li><a href="/wiki/Rinucumab" title="Rinucumab">Rinucumab</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%">Mouse</th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Indium_(111In)_biciromab" title="Indium (111In) biciromab">Biciromab</a><sup>‡</sup></li> <li><a href="/wiki/Indium_(111In)_imciromab" title="Indium (111In) imciromab">Imciromab</a><sup>‡</sup></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%"><a href="/wiki/Fusion_protein" title="Fusion protein">Chimeric</a></th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Abciximab" title="Abciximab">Abciximab</a></li> <li><a href="/wiki/Volociximab" title="Volociximab">Volociximab</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%"><a href="/wiki/Humanized_antibody" title="Humanized antibody">Humanized</a></th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Alacizumab_pegol" title="Alacizumab pegol">Alacizumab pegol</a></li> <li><a href="/wiki/Bevacizumab" title="Bevacizumab">Bevacizumab</a>/<a href="/wiki/Ranibizumab" title="Ranibizumab">Ranibizumab</a></li> <li><a href="/wiki/Bococizumab" title="Bococizumab">Bococizumab</a></li> <li><a href="/wiki/Brolucizumab" title="Brolucizumab">Brolucizumab</a></li> <li><a href="/wiki/Caplacizumab" title="Caplacizumab">Caplacizumab</a></li> <li><a href="/wiki/Concizumab" title="Concizumab">Concizumab</a></li> <li><a href="/wiki/Demcizumab" title="Demcizumab">Demcizumab</a></li> <li><a href="/wiki/Emicizumab" title="Emicizumab">Emicizumab</a></li> <li><a href="/wiki/Etaracizumab" title="Etaracizumab">Etaracizumab</a></li> <li><a href="/wiki/Faricimab" title="Faricimab">Faricimab</a></li> <li><a href="/wiki/Idarucizumab" title="Idarucizumab">Idarucizumab</a></li> <li><a href="/wiki/Ralpancizumab" title="Ralpancizumab">Ralpancizumab</a></li> <li><a href="/wiki/Tadocizumab" title="Tadocizumab">Tadocizumab</a></li> <li><a href="/wiki/Vanucizumab" title="Vanucizumab">Vanucizumab</a></li></ul> </div></td></tr></tbody></table><div></div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%"><a href="/wiki/Neurology" title="Neurology">Neurologic</a></th><td class="navbox-list-with-group navbox-list navbox-odd hlist" style="width:100%;padding:0"><div style="padding:0 0.25em"></div><table class="nowraplinks navbox-subgroup" style="border-spacing:0"><tbody><tr><th scope="row" class="navbox-group" style="width:1%">Human</th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Anti-amyloid_drugs" title="Anti-amyloid drugs">Anti-amyloid drugs</a> <ul><li><a href="/wiki/Aducanumab" title="Aducanumab">Aducanumab</a><sup>‡</sup></li> <li><a href="/wiki/Donanemab" title="Donanemab">Donanemab</a></li> <li><a href="/wiki/Gantenerumab" title="Gantenerumab">Gantenerumab</a><sup>†</sup></li> <li><a href="/wiki/Lecanemab" title="Lecanemab">Lecanemab</a></li></ul></li> <li><a href="/wiki/Erenumab" title="Erenumab">Erenumab</a></li> <li><a href="/wiki/Fasinumab" title="Fasinumab">Fasinumab</a><sup>†</sup></li> <li><a href="/wiki/Fulranumab" title="Fulranumab">Fulranumab</a></li> <li><a href="/wiki/Opicinumab" title="Opicinumab">Opicinumab</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%">Humanized</th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Bapineuzumab" title="Bapineuzumab">Bapineuzumab</a><sup>†</sup></li> <li><a href="/wiki/Crenezumab" title="Crenezumab">Crenezumab</a><sup>†</sup></li> <li><a href="/wiki/Eptinezumab" title="Eptinezumab">Eptinezumab</a></li> <li><a href="/wiki/Fremanezumab" title="Fremanezumab">Fremanezumab</a></li> <li><a href="/wiki/Galcanezumab" title="Galcanezumab">Galcanezumab</a></li> <li><a href="/wiki/Ozanezumab" title="Ozanezumab">Ozanezumab</a></li> <li><a href="/wiki/Ponezumab" title="Ponezumab">Ponezumab</a></li> <li><a href="/wiki/Refanezumab" title="Refanezumab">Refanezumab</a></li> <li><a href="/wiki/Semorinemab" title="Semorinemab">Semorinemab</a></li> <li><a href="/wiki/Solanezumab" title="Solanezumab">Solanezumab</a></li> <li><a href="/wiki/Tanezumab" title="Tanezumab">Tanezumab</a><sup>†</sup></li></ul> </div></td></tr></tbody></table><div></div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%"><a href="/wiki/Angiogenesis_inhibitor" title="Angiogenesis inhibitor">Angiogenesis inhibitor</a></th><td class="navbox-list-with-group navbox-list navbox-odd hlist" style="width:100%;padding:0"><div style="padding:0 0.25em"></div><table class="nowraplinks navbox-subgroup" style="border-spacing:0"><tbody><tr><th id="Humanized" scope="row" class="navbox-group" style="width:1%">Humanized</th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Ranibizumab" title="Ranibizumab">Ranibizumab</a></li></ul> </div></td></tr></tbody></table><div></div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%"><a href="/wiki/Growth_factor" title="Growth factor">Growth factor</a></th><td class="navbox-list-with-group navbox-list navbox-odd hlist" style="width:100%;padding:0"><div style="padding:0 0.25em"></div><table class="nowraplinks navbox-subgroup" style="border-spacing:0"><tbody><tr><th scope="row" class="navbox-group" style="width:1%">Human</th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Bimagrumab" title="Bimagrumab">Bimagrumab</a></li> <li><a href="/wiki/Trevogrumab" title="Trevogrumab">Trevogrumab</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%">Humanized</th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Domagrozumab" title="Domagrozumab">Domagrozumab</a></li> <li><a href="/wiki/Landogrozumab" title="Landogrozumab">Landogrozumab</a></li></ul> </div></td></tr></tbody></table><div></div></td></tr><tr><td class="navbox-abovebelow" colspan="2"><div><div class="hlist"> <ul><li><sup>#</sup><a href="/wiki/WHO_Model_List_of_Essential_Medicines" title="WHO Model List of Essential Medicines">WHO-EM</a></li> <li><sup>‡</sup><a href="/wiki/List_of_withdrawn_drugs" title="List of withdrawn drugs">Withdrawn</a> from market</li> <li><a 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