{"id":4478,"date":"2025-09-24T21:01:24","date_gmt":"2025-09-24T21:01:24","guid":{"rendered":"https:\/\/hcp.biomarin.com\/en-us\/voxzogo\/?page_id=4478"},"modified":"2026-08-26T06:43:27","modified_gmt":"2026-08-26T06:43:27","slug":"pivotal-data","status":"publish","type":"page","link":"https:\/\/hcp.biomarin.com\/en-us\/voxzogo\/pivotal-data\/","title":{"rendered":"VOXZOGO Pivotal Data"},"content":{"rendered":"<div id=\"Linear-growth-1\" class=\"block wrapped-content block-tight-top\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-66446bef527a8\" class=\"block-wysiwyg\">\n            <h1 style=\"text-align: left\">VOXZOGO is FDA approved from birth to increase linear growth in infants and children with achondroplasia and open growth plates<sup>1<\/sup><\/h1>\n<h2 style=\"text-align: left\">Studied in children aged 4 months to &lt;18 years<sup>1-4<\/sup><\/h2>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-6866d8e901e42\" class=\"block wrapped-content block-zero-bottom\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<figure id=\"acf-block-66446bef5298f\">\n    <div class=\"image image-responsive image-align-left\">\n                    <div class=\"image-desktop\">\n\t\t\t    <img decoding=\"async\" class=\"\" src=\"https:\/\/hcp.biomarin.com\/en-us\/voxzogo\/wp-content\/uploads\/sites\/4\/2026\/05\/sFrame-176.svg\" alt=\"\" \/>\t\t\t<\/div>\n\t\t\t<div class=\"image-mobile\">\n\t\t\t    <img decoding=\"async\" class=\"\" src=\"https:\/\/hcp.biomarin.com\/en-us\/voxzogo\/wp-content\/uploads\/sites\/4\/2026\/05\/mGroup-10.svg\" alt=\"\" \/>\t\t\t<\/div>\n            <\/div>\n    <\/figure>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-6644782b1371f\" class=\"block wrapped-content block-tight-top\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-6644782b13747\" class=\"block-wysiwyg\">\n            <p><small><strong>ACH,<\/strong> achondroplasia; <strong>EXT,<\/strong> extension; <strong>OS,<\/strong> observational study.<\/small><\/p>\n<p><small>*Duration of \u22656 months if aged \u22653 months at study entry; duration of \u22653 months if aged &lt;3 months at study entry.<sup>3\u2028<\/sup><\/small><br \/>\n<small><sup>\u2020<\/sup>Participants completed at least 3 or 6 months of an observational run-in growth study (either in CANOPY ACH-OS [Study 901] or CANOPY ACH-2I [Study 206]) to establish their baseline annualized growth velocity.<sup>4,5<\/sup><\/small><\/p>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-6866d8e90208d\" class=\"block wrapped-content bg-band bg-band-secondary\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-6866d8e9020b3\" class=\"block-wysiwyg\">\n            <h2 style=\"text-align: center;margin: 0\"><span style=\"color: #6360a9\">Data continue to be collected in ongoing clinical trials and real-world studies.<sup>8<\/sup><\/span><\/h2>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"Linear-growth-2\" class=\"block wrapped-content block-tight-top block-zero-bottom\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"children-with-achondroplasia\" class=\"block-wysiwyg\">\n            <h2 style=\"text-align: left\">Children with achondroplasia on VOXZOGO grew faster than without treatment, with AGV increase maintained over baseline over 4 years<sup>1,9<\/sup><\/h2>\n    <\/div>\n\n<figure id=\"acf-block-6a71d4e5038c2\">\n    <div class=\"image image-responsive image-rounded image-align-left\">\n                    <div class=\"image-desktop\">\n\t\t\t    <img decoding=\"async\" class=\"\" src=\"https:\/\/hcp.biomarin.com\/en-us\/voxzogo\/wp-content\/uploads\/sites\/4\/2026\/08\/Frame-168.svg\" alt=\"image\" \/>\t\t\t<\/div>\n\t\t\t<div class=\"image-mobile\">\n\t\t\t    <img decoding=\"async\" class=\"\" src=\"https:\/\/hcp.biomarin.com\/en-us\/voxzogo\/wp-content\/uploads\/sites\/4\/2026\/08\/Frame-168-1.svg\" alt=\"image\" \/>\t\t\t<\/div>\n            <\/div>\n    <\/figure>\n\n<div id=\"acf-block-6a71e28eaf925\" class=\"block-wysiwyg\">\n            <h3 style=\"text-align: center\">Mean (\u00b1SD) AGV over time in children aged 5 to 15 years<sup>2,5,9<\/sup><\/h3>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-6866d8e902135\" class=\"block wrapped-content block-zero-top block-zero-bottom\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<figure id=\"acf-block-66446bef5298f\">\n    <div class=\"image image-responsive image-align-left\">\n                    <div class=\"image-desktop\">\n\t\t\t    <img decoding=\"async\" class=\"\" src=\"https:\/\/hcp.biomarin.com\/en-us\/voxzogo\/wp-content\/uploads\/sites\/4\/2026\/08\/Frame-161.svg\" alt=\"Line graph showing annual growth velocity (AGV) over 4 years in children on VOXZOGO\" \/>\t\t\t<\/div>\n\t\t\t<div class=\"image-mobile\">\n\t\t\t    <img decoding=\"async\" class=\"\" src=\"https:\/\/hcp.biomarin.com\/en-us\/voxzogo\/wp-content\/uploads\/sites\/4\/2026\/08\/0006_seesaw-4-1.svg\" alt=\"Line graph showing annual growth velocity (AGV) over 4 years in children on VOXZOGO\" \/>\t\t\t<\/div>\n            <\/div>\n    <\/figure>\n\n<div id=\"acf-block-6a71e28eaf9b8\" class=\"block-wysiwyg\">\n            <h4 style=\"margin: 0px;text-align: left\"><span style=\"color: #c6007e\">Study Design<\/span><\/h4>\n<ul class=\"hcp-biomarin-list-pd\">\n<li><strong>CANOPY ACH-3 (Study 301):<\/strong> Children aged 5 to 15 years were treated with VOXZOGO or placebo for 52 weeks<sup>1,5<\/sup><\/li>\n<li><strong>CANOPY ACH-EXT (Study 302):<\/strong> Long-term efficacy and safety profile of VOXZOGO evaluated in children who continued treatment for up to 4 years in the open-label extension\u00a0study<sup>5,9<\/sup><\/li>\n<\/ul>\n<h4 style=\"margin: 0px;text-align: left\"><span style=\"color: #c6007e\">Primary Endpoint<\/span><\/h4>\n<ul class=\"hcp-biomarin-list-pd\" style=\"text-align: left\">\n<li><strong>Study 301:<\/strong> Change from baseline in AGV at week 52 vs placebo. AGV is a measure of linear growth expressed as change in height or length over 1 year<sup>1<\/sup><\/li>\n<\/ul>\n    <\/div>\n\n<div id=\"acf-block-6a71e28eaf9ea\" class=\"block-wysiwyg\">\n            <p><small><strong>ACH,<\/strong> achondroplasia; <strong>AGV,<\/strong> annualized growth velocity; <strong>CI,<\/strong> confidence interval; <strong>EXT,<\/strong> extension; <strong>LS,<\/strong> least squares; <strong>SD,<\/strong> standard deviation.<\/small><\/p>\n<p><small>*All randomized subjects. 2 patients in the VOXZOGO group discontinued from the study before week 52; the values for these 2 patients were imputed assuming baseline growth rate for the period with missing data.<sup>1<\/sup><br \/>\n<sup>\u2020<\/sup>Difference in LS mean change from baseline. LS means estimated from the ANCOVA (analysis of covariance) model, which included treatment, stratum by sex and Tanner stage, baseline age, baseline AGV, and baseline height Z-score.<sup>1<\/sup><br \/>\n<sup>\u2021<\/sup>Baseline AGV was established in the run-in observational Study 901, based on standing height measurements at least 6 months prior to enrollment in Study 301.<sup>3<\/sup><\/small><\/p>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-68d45bdb26d69\" class=\"block wrapped-content block-zero-top block-zero-bottom\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-68d45bdb26da4\" class=\"block-wysiwyg\">\n            <h2 style=\"text-align: left\">Children treated with VOXZOGO had an increase in height Z-score vs placebo that was maintained over baseline<sup>1,10<\/sup><\/h2>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-68d45bdb28322\" class=\"block split-content equal-bias block-zero-top block-zero-bottom\" data-muted-autoplay=\"false\">\n\t<div class=\"wrapper\">\n\t\t<div class=\"inner-wrapper\">\n\t\t                                                                <div class=\"content-block first-block\">\n                                                                                                                                                                                                                                                                                    \n                                                                                                                \n                                    \n                                    \n                                    <figure>\n                                        <div class=\"image image-responsive\">\n                                                                                            <div class=\"image-desktop\">\n                                                    <img decoding=\"async\" class=\"\" src=\"https:\/\/hcp.biomarin.com\/en-us\/voxzogo\/wp-content\/uploads\/sites\/4\/2026\/08\/Frame-167.svg\" alt=\"image\" \/>                                                <\/div>\n                                                <div class=\"image-mobile\">\n                                                    <img decoding=\"async\" class=\"\" src=\"https:\/\/hcp.biomarin.com\/en-us\/voxzogo\/wp-content\/uploads\/sites\/4\/2026\/08\/Frame-167-1.svg\" alt=\"image\" \/>                                                <\/div>\n                                                                                    <\/div>\n                                                                            <\/figure>\n                                \n                                                    <\/div>\n                    \n                                            <div class=\"content-block second-block\">\n                                                                                                                                                                                                                                                                                    \n                                                                                                                \n                                    \n                                    \n                                    <figure>\n                                        <div class=\"image image-responsive\">\n                                                                                            <div class=\"image-desktop\">\n                                                    <img decoding=\"async\" class=\"\" src=\"https:\/\/hcp.biomarin.com\/en-us\/voxzogo\/wp-content\/uploads\/sites\/4\/2026\/08\/Frame-166.svg\" alt=\"image\" \/>                                                <\/div>\n                                                <div class=\"image-mobile\">\n                                                    <img decoding=\"async\" class=\"\" src=\"https:\/\/hcp.biomarin.com\/en-us\/voxzogo\/wp-content\/uploads\/sites\/4\/2026\/08\/Frame-167-2.svg\" alt=\"image\" \/>                                                <\/div>\n                                                                                    <\/div>\n                                                                            <\/figure>\n                                                                                    <\/div>\n                                                \t\t<\/div>\n\t<\/div>\n<\/div>\n\n<div id=\"acf-block-68d45bdb28397\" class=\"block wrapped-content block-zero-top block-zero-bottom\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-68d45bdb283ca\" class=\"block-wysiwyg\">\n            <h2 style=\"text-align: center\"><span style=\"color: #c6007e\">97% of children on VOXZOGO (58\/60) in the phase 3 pivotal trial remained on treatment during the 1-year study.<sup>1<\/sup><\/span><\/h2>\n    <\/div>\n\n<div id=\"acf-block-66446bef527a8\" class=\"block-wysiwyg\">\n            <p style=\"text-align: left\"><small><strong>ACH,<\/strong> achondroplasia; <strong>AGV,<\/strong> annualized growth velocity; <strong>CI,<\/strong> confidence interval; <strong>EXT,<\/strong> extension; <strong>LS,<\/strong> least squares.<\/small><\/p>\n<p><small>*For Z-score, height measurements were converted to an age- and sex-appropriate Z-score by comparison with Centers for Disease Control and Prevention reference standards for average-stature children.<sup>2,10<\/sup><br \/>\n<sup>\u2020<\/sup>Difference in LS mean change from baseline (VOXZOGO minus placebo). LS means and differences in LS means estimated from an ANCOVA (analysis of covariance) model, which included treatment, stratum defined by sex and Tanner stage, baseline age, baseline AGV, and baseline height Z-score. AII randomized subjects. 2 patients in the VOXZOGO group discontinued from the study before week 52. The values for these patients were imputed for this analysis.<sup>2<\/sup><\/small><\/p>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-6866d8e90224d\" class=\"block wrapped-content bg-band bg-band-primary block-zero-top block-zero-bottom block-remove-bottom-padding\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<figure id=\"acf-block-68d4611f41ae7\">\n    <div class=\"image image-responsive image-rounded image-align-left\">\n                    <div class=\"image-desktop\">\n\t\t\t    <img decoding=\"async\" class=\"\" src=\"https:\/\/hcp.biomarin.com\/en-us\/voxzogo\/wp-content\/uploads\/sites\/4\/2026\/05\/sFrame-677-2-1900x1059.png\" alt=\"Annika at ages 6 and 14, illustrating growth progress before and after taking VOXZOGO\" \/>\t\t\t<\/div>\n\t\t\t<div class=\"image-mobile\">\n\t\t\t    <img decoding=\"async\" class=\"\" src=\"https:\/\/hcp.biomarin.com\/en-us\/voxzogo\/wp-content\/uploads\/sites\/4\/2026\/05\/msFrame-677.png?v=0.171\" alt=\"Annika at ages 6 and 14, illustrating growth progress before and after taking VOXZOGO\" \/>\t\t\t<\/div>\n            <\/div>\n    <\/figure>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-6866d8e90224d\" class=\"block wrapped-content bg-band bg-band-primary block-zero-top block-zero-bottom block-remove-top-padding\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-6866d8e902274\" class=\"block-wysiwyg\">\n            <h2 style=\"text-align: center\">Hear more stories like Annika\u2019s<\/h2>\n<p style=\"text-align: center\"><a class=\"button button-arrow\" href=\"\/en-us\/voxzogo\/patient-stories\/\">Explore Patient Stories<\/a><\/p>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-63f4e940a1489\" class=\"block references block-zero-top block-zero-bottom\">\n    <div class=\"wrapper\">\n\t\t<div class=\"inner-wrapper\">\n\t\t    \t\t\t    <h4>References:\n<\/h4>\n\t\t\t\t\t\t                <ol>\n                                                                                                                        <li><span>VOXZOGO [package insert]. Novato, CA: BioMarin Pharmaceutical Inc; 2024.\n<\/span><\/li>\n                                                                                                                                                <li><span>Savarirayan R, Tofts L, Irving M, et al. Once-daily, subcutaneous vosoritide therapy in children with achondroplasia: a randomised, double-blind, phase 3, placebo-controlled, multicentre trial. <em>Lancet<\/em>. 2020;396(10252):684-692.\n<\/span><\/li>\n                                                                                                                                                <li><span>Savarirayan R, Tofts L, Irving M, et al. Once-daily, subcutaneous vosoritide therapy in children with achondroplasia: a randomised, double-blind, phase 3, placebo-controlled, multicentre trial. <em>Lancet<\/em>. 2020;396(10252):684-692. Supplementary Appendix.\n<\/span><\/li>\n                                                                                                                                                <li><span>Savarirayan R, Wilcox WR, Harmatz P, et al. Vosoritide therapy in children with achondroplasia aged 3-59 months: a multinational, randomised, double-blind, placebo-controlled, phase 2 trial. <em>Lancet Child Adolesc Health.<\/em> 2024;8(1):40-50.\n<\/span><\/li>\n                                                                                                                                                <li><span>Data on file [1]. BioMarin Pharmaceutical Inc; 2025.\n<\/span><\/li>\n                                                                                                                                                <li><span>ClinicalTrials.gov. Identifier: NCT03989947. Accessed March 17, 2026. https:\/\/www.clinicaltrials.gov\/study\/NCT03989947\n<\/span><\/li>\n                                                                                                                                                <li><span>Savarirayan R, Tofts L, Irving M, et al. Safe and persistent growth-promoting effects of vosoritide in children with achondroplasia: 2-year results from an open-label, phase 3 extension study. <em>Genet Med.<\/em> 2021;23(12):2443-2447.\n<\/span><\/li>\n                                                                                                                                                <li><span>ClinicalTrials.gov. Search: Achondroplasia, BioMarin Pharmaceutical. Accessed March 17, 2026. https:\/\/www.clinicaltrials.gov\/search?cond=Achondroplasia&amp;term=BioMarin%20Pharmaceutical&amp;viewType=Table\n<\/span><\/li>\n                                                                                                                                                <li><span>Data on file [2]. BioMarin Pharmaceutical Inc; 2025.\n<\/span><\/li>\n                                                                                                                                                <li><span>Savarirayan R, Irving M, Wilcox WR, et al. Sustained growth-promoting effects of vosoritide in children with achondroplasia from an ongoing phase 3 extension study. <em>Med<\/em>. 2025;6(5):100566.\n<\/span><\/li>\n                                                            <\/ol>\n\t\t\t\t\t<\/div>\n\t<\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"","protected":false},"author":10,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"class_list":["post-4478","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Achondroplasia Treatment Efficacy | VOXZOGO\u00ae Clinical Trial Results<\/title>\n<meta name=\"description\" content=\"Explore achondroplasia treatment outcomes with VOXZOGO\u00ae (vosoritide), including pivotal and long-term clinical trial 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