{"id":5416,"date":"2024-09-26T14:08:15","date_gmt":"2024-09-26T14:08:15","guid":{"rendered":"https:\/\/www.roctavian.com\/en-us\/?page_id=5416"},"modified":"2024-10-21T14:49:28","modified_gmt":"2024-10-21T14:49:28","slug":"roctavian-results","status":"publish","type":"page","link":"https:\/\/www.roctavian.com\/en-us\/roctavian-results\/","title":{"rendered":"ROCTAVIAN RESULTS"},"content":{"rendered":"<div id=\"acf-block-66f592be7e361\" class=\"hero hero-roctavian\">\n\t<div class=\"hero-background-image hero-background-image-desktop\" style=\"background-image: url(https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2024\/09\/results_hero.jpg?v=0.84);\"><\/div>\n\t<div class=\"hero-background-image hero-background-image-mobile\" style=\"background-image: url(https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2024\/10\/results-hero-mobile.jpg?v=0.84);\"><\/div>\n\t<div class=\"overlay\"><\/div>\n\n\t<div class=\"hero-content\">\n\t\t<div class=\"title-area\">\n\t\t\t\t\t\t                <img decoding=\"async\" class=\"branding\" src=\"https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2024\/10\/results_branding.svg\" alt=\"\" \/>            \t\t<\/div>\t\t\n                            <div class=\"text-area\">\n                <div class=\"text-area-content\">\n                                        <div class=\"text\">\n                        <p>*Andrew W. was dosed with ROCTAVIAN in 2018 as a clinical study participant.<\/p>\n                    <\/div>\n                                    <\/div>\n            <\/div>\n        \t<\/div>\n            <div class=\"wrapper\">\n            <div class=\"inner-wrapper\">\n                <div class=\"image-caption\">\n                    <p>Andrew W., dad, husband, runner, and member of the hemophilia A community*<\/p>\n                <\/div>\n            <\/div>\n        <\/div>\n\t<\/div>\n    <div class=\"hero-footer hero-footer-roctavian\">\n        <div class=\"wrapper\">\n            <div class=\"inner-wrapper\">\n                <p>ROCTAVIAN was FDA approved based on 3 years of data<\/p>\n            <\/div>\n        <\/div>\n    <\/div>\n\n\n<div id=\"acf-block-66f578b1221f1\" class=\"block wrapped-content bg-band block-zero-top\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-66f578b122427\" class=\"block-wysiwyg\">\n            <h2 style=\"text-align: center\">Get to know this one-time treatment<\/h2>\n    <\/div>\n\n<figure id=\"acf-block-66fabef2b767e\">\n    <div class=\"image image-responsive image-rounded\">\n                    <div class=\"image-desktop\">\n\t\t\t    <img decoding=\"async\" class=\"\" src=\"https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2024\/09\/title_border.svg\" alt=\"\" \/>\t\t\t<\/div>\n\t\t\t<div class=\"image-mobile\">\n\t\t\t    <img decoding=\"async\" class=\"\" src=\"https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2024\/09\/title_border_mobile.svg\" alt=\"\" \/>\t\t\t<\/div>\n            <\/div>\n    <\/figure>\n\n<div id=\"acf-block-66fabef2b76b7\" class=\"block-wysiwyg\">\n            <ul>\n<li>ROCTAVIAN<sup>\u00ae<\/sup> helps people make their own Factor VIII, so they may be able to:\n<ul>\n<li>Maintain Factor VIII levels in the mild range or better<\/li>\n<li>Experience bleed control for years<\/li>\n<li>Stop and stay off continuous prophylaxis for years<\/li>\n<\/ul>\n<\/li>\n<li>Studied for years in the longest and largest gene therapy clinical study in severe hemophilia A*\u2014and data continue to be collected<\/li>\n<\/ul>\n<p><small>*At approval, ROCTAVIAN had the <strong>longest<\/strong> and <strong>largest<\/strong> Phase 3 clinical study in severe hemophilia A.<\/small><\/p>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"3-years-after-ROCTAVIAN\" class=\"block wrapped-content block-tight-top\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-66f578b1224a1\" class=\"block-wysiwyg\">\n            <h2 style=\"text-align: center\">3 years after ROCTAVIAN, the average Factor VIII activity level was 34%*<\/h2>\n    <\/div>\n\n<figure id=\"acf-block-66f578b122737\">\n    <div class=\"image image-responsive image-rounded\">\n                    <div class=\"image-desktop\">\n\t\t\t    <img decoding=\"async\" class=\"\" src=\"https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2024\/09\/title_border.svg\" alt=\"\" \/>\t\t\t<\/div>\n\t\t\t<div class=\"image-mobile\">\n\t\t\t    <img decoding=\"async\" class=\"\" src=\"https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2024\/09\/title_border_mobile.svg\" alt=\"\" \/>\t\t\t<\/div>\n            <\/div>\n    <\/figure>\n\n<figure id=\"acf-block-66f578b122737\">\n    <div class=\"image image-rounded\">\n                    <img decoding=\"async\" class=\"\" src=\"https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2024\/09\/3_yrs_graph.png?v=0.84\" alt=\"Line graph showing average factor VIII activity levels with ROCTAVIAN 3 years after treatment\" \/>            <\/div>\n    <\/figure>\n\n<div id=\"acf-block-66f578b122776\" class=\"block-wysiwyg\">\n            <ul>\n<li>Factor VIII levels can be measured using either a one-stage assay (shown here) or a chromogenic assay. One-stage results consistently show higher Factor VIII levels.<\/li>\n<li>Median is the middle number in a list of numbers arranged from smallest to largest<\/li>\n<li>ROCTAVIAN was studied in 112 people whose data were collected for at least 6 months before their infusion (rollover population) and 22 people who immediately received their infusion (directly enrolled population). In the rollover population, the average Factor VIII level was 34% at Year 3<\/li>\n<li>Factor VIII activity levels are based on definitions from the World Federation of Hemophilia. Here, we define mild as 5% to less than 40% and near-normal to normal as 40% to equal to or less than 150%<\/li>\n<li>Some people did not respond to treatment or lost response to treatment. It is not possible to predict if and how much you may benefit from ROCTAVIAN<\/li>\n<\/ul>\n<p><small>*The 3-year follow-up period began 5 weeks or more after administration and consisted of a median follow-up of 3 years with a range of 1.7 to 3.7 years.<\/small><br \/>\n<small><sup>\u2020<\/sup>Standard deviation (SD) shows how spread out the data are from the average.<\/small><\/p>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-66fabef2b77fb\" class=\"block wrapped-content bg-band bg-band-primary block-zero-bottom block-remove-top-padding block-remove-bottom-padding\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-66fabef2b7825\" class=\"block-wysiwyg\">\n            <h2 style=\"text-align: center;margin-top: 1rem\">Years of Factor VIII production with one dose<\/h2>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"Years-of-Factor-VIII-production\" class=\"block wrapped-content block-tight-top block-tight-bottom\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<figure id=\"acf-block-66f578b122810\">\n    <div class=\"image image-responsive image-rounded\">\n                    <div class=\"image-desktop\">\n\t\t\t    <img decoding=\"async\" class=\"\" src=\"https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2024\/09\/2.1_86-1900x617.png\" alt=\"Infographic showing that 86% of people had their Factor VIII levels increased to the mild range or above at 3 years\" \/>\t\t\t<\/div>\n\t\t\t<div class=\"image-mobile\">\n\t\t\t    <img decoding=\"async\" class=\"\" src=\"https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2024\/09\/86_pervcent_gfc_mobile.jpg?v=0.84\" alt=\"Infographic showing that 86% of people had their Factor VIII levels increased to the mild range or above at 3 years\" \/>\t\t\t<\/div>\n            <\/div>\n            <figcaption><p>*The World Federation of Hemophilia defines mild range as 5% to less than 40%.<\/p>\n<\/figcaption>\n    <\/figure>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"IMG-banner\" class=\"block wrapped-content block-tight-top block-tight-bottom\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<figure id=\"acf-block-66fa951ac1cc4\">\n    <div class=\"image image-responsive image-rounded\">\n                    <div class=\"image-desktop\">\n\t\t\t    <img decoding=\"async\" class=\"\" src=\"https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2024\/09\/2.1_Quote-image_Desktop.png?v=0.84\" alt=\"What really got me excited about ROCTAVIAN was just that possibility that I actually could produce Factor VIII.&#039; - Andrew W., dosed with ROCTAVIAN in 2018 as a clinical study participant.\" \/>\t\t\t<\/div>\n\t\t\t<div class=\"image-mobile\">\n\t\t\t    <img decoding=\"async\" class=\"\" src=\"https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2024\/09\/testimonial_mobile.jpg?v=0.84\" alt=\"What really got me excited about ROCTAVIAN was just that possibility that I actually could produce Factor VIII.&#039; - Andrew W., dosed with ROCTAVIAN in 2018 as a clinical study participant.\" \/>\t\t\t<\/div>\n            <\/div>\n    <\/figure>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"Improved-bleed-control\" class=\"block wrapped-content bg-band block-tight-top block-zero-bottom\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-66f578b122bed\" class=\"block-wysiwyg\">\n            <h2 style=\"text-align: center\">ROCTAVIAN improved bleed control for years<\/h2>\n    <\/div>\n\n<figure id=\"acf-block-66fabef2b7931\">\n    <div class=\"image image-responsive image-rounded\">\n                    <div class=\"image-desktop\">\n\t\t\t    <img decoding=\"async\" class=\"\" src=\"https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2024\/09\/title_border.svg\" alt=\"\" \/>\t\t\t<\/div>\n\t\t\t<div class=\"image-mobile\">\n\t\t\t    <img decoding=\"async\" class=\"\" src=\"https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2024\/09\/title_border_mobile.svg\" alt=\"\" \/>\t\t\t<\/div>\n            <\/div>\n    <\/figure>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-66f578b123ba7\" class=\"block split-content bg-band block-zero-top block-zero-bottom block-remove-top-padding\" data-muted-autoplay=\"false\">\n\t<div class=\"wrapper\">\n\t\t<div class=\"inner-wrapper\">\n\t\t                                                                <div class=\"content-block\">\n                                                                                                                                                                                                                                                                                    \n                                    \n                                                                                                                \n                                    \n                                    <figure>\n                                        <div class=\"image image-rounded\">\n                                                                                            <img decoding=\"async\" class=\"\" src=\"https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2024\/09\/proven_reduction_gfx.png?v=0.84\" alt=\"Infographic showing that after ROCTAVIAN, there was a 91% median ABR reduction\" \/>                                                                                    <\/div>\n                                                                            <\/figure>\n                                                                                    <\/div>\n                    \n                                            <div class=\"content-block\">\n                                                                                                <ul>\n<li>Before ROCTAVIAN, the average ABR was 5.4. After ROCTAVIAN, the average ABR dropped to 2.6<sup>\u2020<\/sup><\/li>\n<li>Results are based on 112 people whose data were collected for at least 6 months before receiving ROCTAVIAN and compared with their data over the 3-year follow-up period<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><small>*The 3-year follow-up period began 5 weeks or more after administration and consisted of a median follow-up of 3 years with a range of 1.7 to 3.7 years. Median is the middle number in a list of numbers arranged from smallest to largest.<\/small><br \/>\n<small><sup>\u2020<\/sup>13 of 112 people (12%) returned to continuous prophylaxis after ROCTAVIAN, with a median start time at 2.3 years with a range of 0.1 to 3.3 years. An ABR of 35 was added to account for the periods when these people were on prophylaxis.<\/small><\/p>\n                                                                                    <\/div>\n                                                \t\t<\/div>\n\t<\/div>\n<\/div>\n\n<div id=\"acf-block-66fabef2b8667\" class=\"block wrapped-content bg-band bg-band-primary block-zero-top block-zero-bottom block-remove-top-padding block-remove-bottom-padding\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-66fabef2b868a\" class=\"block-wysiwyg\">\n            <h2 style=\"text-align: center;margin-top: 1rem\">You could be free from prophylaxis for years<\/h2>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"90-out-of-112\" class=\"block wrapped-content block-zero-bottom\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-66f578b123c3c\" class=\"block-wysiwyg\">\n            <h2 style=\"text-align: center\">90 out of 112 people responded to ROCTAVIAN, stopped,<br \/>\nand stayed off continuous prophylaxis*<sup>\u2020<\/sup><\/h2>\n    <\/div>\n\n<figure id=\"acf-block-66fabef2b8712\">\n    <div class=\"image image-responsive image-rounded\">\n                    <div class=\"image-desktop\">\n\t\t\t    <img decoding=\"async\" class=\"\" src=\"https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2024\/09\/title_border.svg\" alt=\"\" \/>\t\t\t<\/div>\n\t\t\t<div class=\"image-mobile\">\n\t\t\t    <img decoding=\"async\" class=\"\" src=\"https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2024\/09\/title_border_mobile.svg\" alt=\"\" \/>\t\t\t<\/div>\n            <\/div>\n    <\/figure>\n\n<div id=\"acf-block-66f578b123c3c\" class=\"block-wysiwyg\">\n            <ul>\n<li>Results are based on 112 people whose data were collected for at least 6 months before receiving ROCTAVIAN and compared with their data over the 3-year follow-up period<sup>\u2021<\/sup><\/li>\n<\/ul>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"img\" class=\"block split-content content-align-top block-zero-top\" data-muted-autoplay=\"false\">\n\t<div class=\"wrapper\">\n\t\t<div class=\"inner-wrapper\">\n\t\t                                                                <div class=\"content-block\">\n                                                                                                                                                                                                                                                                                    \n                                    \n                                                                                                                \n                                    \n                                    <figure>\n                                        <div class=\"image image-rounded\">\n                                                                                            <img decoding=\"async\" class=\"\" src=\"https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2024\/09\/97_percent_gfx@2x.png?v=0.84\" alt=\"Infographic showing that after ROCTAVIAN, infusions reduced by 97%\" \/>                                                                                    <\/div>\n                                                                            <\/figure>\n                                                                                    <\/div>\n                    \n                                            <div class=\"content-block\">\n                                                                                                                                                                                                                                                                                    \n                                    \n                                                                                                                \n                                    \n                                    <figure>\n                                        <div class=\"image image-rounded\">\n                                                                                            <img decoding=\"async\" class=\"\" src=\"https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2024\/09\/2.1_Needle-Piles-1900x2077.png\" alt=\"\" \/>                                                                                    <\/div>\n                                                                            <\/figure>\n                                                                                    <\/div>\n                                                \t\t<\/div>\n\t<\/div>\n<\/div>\n\n<div id=\"acf-block-66fa951ac2d48\" class=\"block wrapped-content block-tight-top block-tight-bottom\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-66fa951ac2d79\" class=\"block-wysiwyg\">\n            <p>After ROCTAVIAN, your doctor will monitor your lab results and talk to you about whether you can stop prophylaxis and whether you should start prophylaxis again if stopped. In ROCTAVIAN clinical studies, patients who did not respond to treatment or lost response to treatment were able to resume prophylaxis.<\/p>\n<p>Your doctor will also discuss with you whether and how you should treat for any surgeries, procedures, injuries, or bleeds.<\/p>\n<p><small>*ROCTAVIAN worked for 80% (90\/112) of people in the rollover population and 68% (15\/22) of people in the directly enrolled population throughout the 3-year follow-up period.<\/small><br \/>\n<small><sup>\u2020<\/sup>Prophylaxis is defined as the ongoing use of Factor VIII or another treatment to prevent bleeds.<\/small><br \/>\n<small><sup>\u2021<\/sup>The 3-year follow-up period began 5 weeks or more after administration and consisted of a median follow-up of 3 years with a range of 1.7 to 3.7 years.<\/small><br \/>\n<small><sup>\u00a7<\/sup>Data were collected for 6 months, and those results were annualized.<\/small><\/p>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-66fabef2b885b\" class=\"block wrapped-content bg-band bg-band-primary block-tight-bottom block-remove-top-padding block-remove-bottom-padding\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-66fabef2b887a\" class=\"block-wysiwyg\">\n            <h2 style=\"text-align: center;margin-top: 1rem\">ROCTAVIAN clinical study details<\/h2>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"largest-clinical-study\" class=\"block wrapped-content block-tight-top block-tight-bottom\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-66f579cedbfa8\" class=\"block-wysiwyg\">\n            <h2 style=\"text-align: center\">The longest and largest gene therapy clinical study in severe hemophilia A*<\/h2>\n    <\/div>\n\n<figure id=\"acf-block-66fabef2b88d0\">\n    <div class=\"image image-responsive image-rounded\">\n                    <div class=\"image-desktop\">\n\t\t\t    <img decoding=\"async\" class=\"\" src=\"https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2024\/09\/title_border.svg\" alt=\"\" \/>\t\t\t<\/div>\n\t\t\t<div class=\"image-mobile\">\n\t\t\t    <img decoding=\"async\" class=\"\" src=\"https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2024\/09\/title_border_mobile.svg\" alt=\"\" \/>\t\t\t<\/div>\n            <\/div>\n    <\/figure>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"no-border\" class=\"block cards cards-2-col block-zero-bottom\">\n\t<div class=\"wrapper\">\n\t\t<div class=\"inner-wrapper\">\n\t\t\t<div class=\"cards-title\">\n\t\t\t    \t\t\t\t\t\t\t<\/div>\n\t\t\t<div class=\"cards-wrapper\">\n\t\t\t    \n<div id=\"acf-block-66fabef2b91a1\" class=\"card card-inner-image card-inner-image-medium\" data-muted-autoplay=\"false\">\n        <div class=\"card-content\">\n                    <img decoding=\"async\" class=\"\" src=\"https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2024\/09\/3yrs_chart_icon.png?v=0.84\" alt=\"\" \/>                            <h4>3 years of data so far\n<\/h4>\n        \n                                                                                                            <ul>\n<li>At BioMarin, we\u2019re committed to reporting study results for years to come<\/li>\n<\/ul>\n                                                                                    <\/div>\n<\/div>\n\n<div id=\"acf-block-66fabef2b9216\" class=\"card card-inner-image card-inner-image-medium\" data-muted-autoplay=\"false\">\n        <div class=\"card-content\">\n                    <img decoding=\"async\" class=\"\" src=\"https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2024\/09\/people_icon.png?v=0.84\" alt=\"\" \/>                            <h4>134 people enrolled<sup>\u2020<\/sup>\n<\/h4>\n        \n                                                                                                            <ul>\n<li>112 people whose data were collected for at least 6 months before their infusion (rollover population)<\/li>\n<li>22 people who immediately received their infusion (directly enrolled population)<\/li>\n<\/ul>\n                                                                                    <\/div>\n<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t<\/div>\n<\/div>\n\n<div id=\"acf-block-66fabef2b924f\" class=\"block wrapped-content block-zero-top\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-66fabef2b9272\" class=\"block-wysiwyg\">\n            <p>Get <a href=\"https:\/\/www.roctavian.com\/en-us\/safety\/\">safety information<\/a> from the ROCTAVIAN clinical study.<\/p>\n<p><small>*At approval, ROCTAVIAN had the longest and largest Phase 3 clinical study.<\/small><br \/>\n<small><sup>\u2020<\/sup>As of November 2023.<\/small><\/p>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-66fbd83720222\" class=\"block contact-representative block-zero-top\">\n\t<div class=\"wrapper\">\n\t\t<div class=\"inner-wrapper\">\n\t\t\t<div class=\"cta-content\">\n\t\t\t                        <div class=\"content-block\">\n                                                    <h2 class=\"h3\">Want to learn more about ROCTAVIAN study results?\n<\/h2>\n                                                                            <p>Connect with a BioMarin representative.<\/p>\n                                            <\/div>\n\t\t\t\t\t\t\t\t                    <div class=\"content-block\">\n                        <p><a class=\"button button-ghost\" href=\"https:\/\/www.roctavian.com\/en-us\/connect-with-us\/\" target=\"_self\">CONNECT WITH US<\/a><\/p>\n                    <\/div>\n                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