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Domain > www.elevidyshcp.com
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No
DNS Resolutions
Date
IP Address
2024-07-07
13.249.9.75
(
ClassC
)
2026-02-19
54.204.43.126
(
ClassC
)
Port 80
HTTP/1.1 301 Moved PermanentlyServer: nginxDate: Tue, 10 Feb 2026 09:28:58 GMTContent-Type: text/html; charsetiso-8859-1Content-Length: 236X-Content-Type-Options: nosniffStrict-Transport-Security: max-age31536000; includeSubdomains;Location: https://www.elevidyshcp.com/Cache-Control: max-age1209600Expires: Tue, 24 Feb 2026 09:28:58 GMTX-Request-ID: v-edab5858-0662-11f1-a398-334a9352eb4bAge: 786647Via: varnishX-Cache: HITX-Cache-Hits: 173Connection: keep-alive !DOCTYPE HTML PUBLIC -//IETF//DTD HTML 2.0//EN>html>head>title>301 Moved Permanently/title>/head>body>h1>Moved Permanently/h1>p>The document has moved a hrefhttps://www.elevidyshcp.com/>here/a>./p>/body>/html>
Port 443
HTTP/1.1 200 OKServer: nginxDate: Thu, 19 Feb 2026 11:59:47 GMTContent-Type: text/html; charsetUTF-8Content-Length: 57250Connection: keep-aliveCache-Control: max-age2764800, publicX-Drupal-Dynamic-Cache: MISSContent-language: enX-Content-Type-Options: nosniffX-Frame-Options: SAMEORIGINExpires: Sun, 19 Nov 1978 05:00:00 GMTVary: Cookie,Accept-EncodingX-Generator: Drupal 10 (https://www.drupal.org)X-Drupal-Cache: MISSStrict-Transport-Security: max-age31536000; includeSubdomains;Last-Modified: Wed, 18 Feb 2026 03:12:59 GMTX-Request-ID: v-ba48483e-0c77-11f1-bf67-8b83f73753d4X-AH-Environment: prodAge: 118007ETag: W/1771384379-gzipVia: varnishX-Cache: HITX-Cache-Hits: 743Accept-Ranges: bytes !DOCTYPE html>html langen dirltr prefixog: https://ogp.me/ns#> head> meta charsetutf-8 />meta namedescription contentLearn about ELEVIDYS (delandistrogene moxeparvovec-rokl). />link relshortlink hrefhttps://www.elevidyshcp.com/ />link relcanonical hrefhttps://www.elevidyshcp.com/ />meta propertyog:title 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data-drupal-messages-fallback classhidden>/div> /section> nav classnavbar navbar-expand-xl px-3 px-xl-0 pt-xl-0 idnavbar-main> a classlogo px-xl-5 href/> img classlogo img-fluid src/sites/elevidyshcp/themes/custom/elevidys_barrio/Elevidys-logo.svg width150 altElevidys logo> /a> button classbtn navbar-toggler navbar-toggler-right typebutton data-bs-togglecollapse data-bs-target#CollapsingNavbar aria-controlsCollapsingNavbar aria-expandedfalse aria-labelToggle navigation> svg classicon-open width35 height35 viewBox0 0 15 15 fillnone xmlnshttp://www.w3.org/2000/svg>path dM2.5 4C2.22386 4 2 4.22386 2 4.5C2 4.77614 2.22386 5 2.5 5H12.5C12.7761 5 13 4.77614 13 4.5C13 4.22386 12.7761 4 12.5 4H2.5ZM2 7.5C2 7.22386 2.22386 7 2.5 7H12.5C12.7761 7 13 7.22386 13 7.5C13 7.77614 12.7761 8 12.5 8H2.5C2.22386 8 2 7.77614 2 7.5ZM2 10.5C2 10.2239 2.22386 10 2.5 10H12.5C12.7761 10 13 10.2239 13 10.5C13 10.7761 12.7761 11 12.5 11H2.5C2.22386 11 2 10.7761 2 10.5Z fillcurrentColor fill-ruleevenodd 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classvisually-hidden idblock-elevidys-barrio-main-menu-menu>Main navigation/h2> ul classclearfix nav navbar-nav> li classnav-item menu-item--expanded dropdown> a href classnav-link dropdown-toggle d-flex d-xl-block align-items-center justify-content-between nav-link-click-first-dropdown nav-link- data-bs-toggledropdown aria-expandedfalse aria-haspopuptrue> About ELEVIDYS svg classd-xl-none width25 height25 viewBox0 0 15 15 fillnone xmlnshttp://www.w3.org/2000/svg>path dM3.13523 6.15803C3.3241 5.95657 3.64052 5.94637 3.84197 6.13523L7.5 9.56464L11.158 6.13523C11.3595 5.94637 11.6759 5.95657 11.8648 6.15803C12.0536 6.35949 12.0434 6.67591 11.842 6.86477L7.84197 10.6148C7.64964 10.7951 7.35036 10.7951 7.15803 10.6148L3.15803 6.86477C2.95657 6.67591 2.94637 6.35949 3.13523 6.15803Z fillcurrentColor fill-ruleevenodd clip-ruleevenodd>/path>/svg> /a> ul classdropdown-menu> li classdropdown-item> a href/about-elevidys/mechanism-of-action classnav-link--about-elevidys-mechanism-of-action data-drupal-link-system-pathnode/26>Mechanism of action/a> /li> li classdropdown-item> a href/about-elevidys/importance-of-treatment classnav-link--about-elevidys-importance-of-treatment data-drupal-link-system-pathnode/31>Importance of treatment/a> /li> /ul> /li> li classnav-item menu-item--expanded dropdown> a href classnav-link dropdown-toggle d-flex d-xl-block align-items-center justify-content-between nav-link-click-first-dropdown nav-link- data-bs-toggledropdown aria-expandedfalse aria-haspopuptrue> Results & Safety svg classd-xl-none width25 height25 viewBox0 0 15 15 fillnone xmlnshttp://www.w3.org/2000/svg>path dM3.13523 6.15803C3.3241 5.95657 3.64052 5.94637 3.84197 6.13523L7.5 9.56464L11.158 6.13523C11.3595 5.94637 11.6759 5.95657 11.8648 6.15803C12.0536 6.35949 12.0434 6.67591 11.842 6.86477L7.84197 10.6148C7.64964 10.7951 7.35036 10.7951 7.15803 10.6148L3.15803 6.86477C2.95657 6.67591 2.94637 6.35949 3.13523 6.15803Z fillcurrentColor fill-ruleevenodd clip-ruleevenodd>/path>/svg> /a> ul classdropdown-menu> li classdropdown-item> a href/results/study-design classnav-link--results-study-design data-drupal-link-system-pathnode/36>Study design overview/a> /li> li classdropdown-item> a href/results/results-ambulatory classnav-link--results-results-ambulatory data-drupal-link-system-pathnode/41>Results: ambulatory patients/a> /li> li classdropdown-item> a href/results/results-nonambulatory classnav-link--results-results-nonambulatory data-drupal-link-system-pathnode/176>Results: non-ambulatory patients/a> /li> li classdropdown-item> a href/results/adverse-events classnav-link--results-adverse-events data-drupal-link-system-pathnode/46>Adverse events/a> /li> li classdropdown-item> a href/results/safety classnav-link--results-safety data-drupal-link-system-pathnode/171>Important safety information/a> /li> /ul> /li> li classnav-item menu-item--expanded dropdown> a href classnav-link dropdown-toggle d-flex d-xl-block align-items-center justify-content-between nav-link-click-first-dropdown nav-link- data-bs-toggledropdown aria-expandedfalse aria-haspopuptrue> Treating with ELEVIDYS svg classd-xl-none width25 height25 viewBox0 0 15 15 fillnone xmlnshttp://www.w3.org/2000/svg>path dM3.13523 6.15803C3.3241 5.95657 3.64052 5.94637 3.84197 6.13523L7.5 9.56464L11.158 6.13523C11.3595 5.94637 11.6759 5.95657 11.8648 6.15803C12.0536 6.35949 12.0434 6.67591 11.842 6.86477L7.84197 10.6148C7.64964 10.7951 7.35036 10.7951 7.15803 10.6148L3.15803 6.86477C2.95657 6.67591 2.94637 6.35949 3.13523 6.15803Z fillcurrentColor fill-ruleevenodd clip-ruleevenodd>/path>/svg> /a> ul classdropdown-menu> li classdropdown-item menu-item--collapsed> a href/treatment-process/eligibility classnav-link--treatment-process-eligibility data-drupal-link-system-pathnode/51>Determining eligibility/a> /li> li classdropdown-item menu-item--collapsed> a href/treatment-process/preinfusion classnav-link--treatment-process-preinfusion data-drupal-link-system-pathnode/56>Pre-infusion preparation/a> /li> li classdropdown-item menu-item--collapsed> a href/treatment-process/infusing-elevidys classnav-link--treatment-process-infusing-elevidys data-drupal-link-system-pathnode/61>Infusing ELEVIDYS/a> /li> li classdropdown-item menu-item--collapsed> a href/treatment-process/postinfusion classnav-link--treatment-process-postinfusion data-drupal-link-system-pathnode/66>Postinfusion monitoring/a> /li> /ul> /li> li classnav-item menu-item--expanded dropdown> a href classnav-link dropdown-toggle d-flex d-xl-block align-items-center justify-content-between nav-link-click-first-dropdown nav-link- data-bs-toggledropdown aria-expandedfalse aria-haspopuptrue> Getting Started & Resources svg classd-xl-none width25 height25 viewBox0 0 15 15 fillnone xmlnshttp://www.w3.org/2000/svg>path dM3.13523 6.15803C3.3241 5.95657 3.64052 5.94637 3.84197 6.13523L7.5 9.56464L11.158 6.13523C11.3595 5.94637 11.6759 5.95657 11.8648 6.15803C12.0536 6.35949 12.0434 6.67591 11.842 6.86477L7.84197 10.6148C7.64964 10.7951 7.35036 10.7951 7.15803 10.6148L3.15803 6.86477C2.95657 6.67591 2.94637 6.35949 3.13523 6.15803Z fillcurrentColor fill-ruleevenodd clip-ruleevenodd>/path>/svg> /a> ul classdropdown-menu> li classdropdown-item> a href/support/getting-started classnav-link--support-getting-started data-drupal-link-system-pathnode/186>Getting started/a> /li> li classdropdown-item> a href/support/resources classnav-link--support-resources data-drupal-link-system-pathnode/76>Resources/a> /li> li classdropdown-item> a href/support/treatment-centers classnav-link--support-treatment-centers data-drupal-link-system-pathnode/16>Treatment centers/a> /li> li classdropdown-item> a href/support/sareptassist classnav-link--support-sareptassist data-drupal-link-system-pathnode/71>SareptAssist/a> /li> /ul> /li> /ul> /nav> nav classnavbar order-xl-0 d-xl-flex justify-content-xl-end utility-menu idnavbar-top> section classrow region region-secondary-menu> nav rolenavigation aria-labelledbyblock-elevidys-barrio-utilitymenu-menu idblock-elevidys-barrio-utilitymenu classblock block-menu navigation menu--utility-menu> h2 classvisually-hidden idblock-elevidys-barrio-utilitymenu-menu>Utility Menu/h2> ul classclearfix nav> li classnav-item> a href/pi target_blank classnav-link nav-link--pi data-drupal-link-system-pathmedia/196>Prescribing Information/a> /li> li classnav-item> a href#isi classsticky-drawer-toggle position-static text-normal nav-link sticky-drawer-toggleposition-statictext-normal nav-link-isi>Important Safety Information/a> /li> li classnav-item> a hrefhttps://www.elevidys.com/ classnav-link nav-link-https--wwwelevidyscom->For Patients/a> /li> li classnav-item> a href/contact-us classrequest-information nav-link nav-link--contact-us data-drupal-link-system-pathnode/21>Contact Us/a> /li> li classnav-item> a href/support/treatment-centers classtreatment-centers nav-link nav-link--support-treatment-centers data-drupal-link-system-pathnode/16>Treatment centers/a> /li> /ul> /nav> /section> /nav> /div> /nav> /header> div idmain-wrapper classlayout-main-wrapper clearfix> div idmain classcontainer-fluid> div classrow row-offcanvas row-offcanvas-left clearfix> main classmain-content col idcontent rolemain> section classsection> a href#main-content idmain-content tabindex-1>/a> div idblock-elevidys-barrio-content classblock block-system block-system-main-block> div classcontent> article classnode node--type-page node--view-mode-full clearfix> header> /header> div classnode__content clearfix> div classfield field--name-field-paragraphs field--type-entity-reference-revisions field--label-hidden field__items> div classfield__item> div classparagraph paragraph--type--section paragraph--view-mode--default> div classsection-layout> div classlayout--remove-bottom-border layout--remove-top-border mt-0 pt-0 gy-0 gx-0 layout layout--elevidys-barrio-grid-row-1 row> div classlayout__region layout__region--col1 col> div classparagraph paragraph--type--hero-section paragraph--view-mode--default> section classhero-section_container container> div classhero-section_content> h1 classhero-section_h1> div classfield field--name-field-hero-section-heading field--type-string field--label-hidden field__item>CELEBRATE THIS MOMENT/div> /h1> h2 classhero-section_h2> div classfield field--name-field-hero-section-subheading field--type-string field--label-hidden field__item>A SIGNIFICANT MILESTONE IN THE TREATMENT OF DUCHENNE¹/div> /h2> div data-component-idelevidys_barrio:text> div classclearfix text-formatted field field--name-field-hero-section-body field--type-text-long field--label-hidden field__item>p>ELEVIDYS is an adeno-associated virus vector-based gene therapy indicated for the treatment of Duchenne muscular dystrophy (DMD) in both ambulatory and non-ambulatory patients who are at least 4 years of age with a confirmed mutation in the em>DMD/em> gene./p>p>Use in non-ambulatory patients is approved under accelerated approval based on expression of ELEVIDYS micro-dystrophin (or “micro-dystrophin”) in skeletal muscle. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s)./p>/div> /div> /div> div classhero-slider-block> lottie-player src/sites/elevidyshcp/files/2024-09/ELE_HCP_Home_Crecent_3_001.json backgroundtransparent speed1 direction1 modenormal autoplay>/lottie-player> div classimage> div classcarousel carousel-fade slide data-bs-ridecarousel> div classcarousel-inner> div classcarousel-item active> div classslidestylebackground-image: url(/sites/elevidyshcp/files/2024-09/Home-hero-image-Jaylen-desktop.png);>/div> /div> div classcarousel-item> div classslidestylebackground-image: url(/sites/elevidyshcp/files/2024-09/Home-hero-image-Thomas-desktop.png);>/div> /div> div classcarousel-item> div classslidestylebackground-image: url(/sites/elevidyshcp/files/2024-09/Home-hero-image-Andrew-1-desktop.png);>/div> /div> div classcarousel-item> div classslidestylebackground-image: url(/sites/elevidyshcp/files/2024-09/Home-hero-image-Max-desktop.png);>/div> /div> /div> /div> /div> /div>/section>section classhero-section_container container> div classhero-link> a href/results/results-ambulatory classhero-section_button btn btn--primary btn-outline-primary rounded-pill btn--has-icon mt-2> See clinical trial results/a> /div>/section> /div> div classparagraph paragraph--type--lotties paragraph--view-mode--default> div classlotties> div classlotties__authoring>Lotties/div> lottie-player classlotties__lottie src/sites/elevidyshcp/files/2024-08/ELE_HCP_Home_Crecent_2_001.json styletop: 510px;left: -381px;width: 727px;height: 1550px;>/lottie-player> div classlotties__authoring>1 - src: /sites/elevidyshcp/files/2024-08/ELE_HCP_Home_Crecent_2_001.json / styles: top: 510px;left: -381px;width: 727px;height: 1550px; / flip x: 0/div> /div> /div> /div> /div> /div> /div>/div> div classfield__item> div classhome-stats paragraph paragraph--type--section paragraph--view-mode--default> div classsection-layout> div classlayout-bg-secondary layout layout--elevidys-barrio-grid-row-1> div classcontainer container--narrow> div classrow> div classlayout__region layout__region--col1 col> div classparagraph paragraph--type--text paragraph--view-mode--default> div data-component-idelevidys_barrio:text> h3 classtext-align-center>Real-world experiencesup>2/sup>/h3>/div> /div> div classparagraph paragraph--type--stats paragraph--view-mode--default> div classstat__container > div data-component-idelevidys_barrio:statistic classstat> svg xmlnshttp://www.w3.org/2000/svg fill#425cc7 viewbox0 0 221.034 221.033> g transformtranslate(1.225 1.225)> circle cx101.026 cy101.026 r101.026 transformtranslate(15.291 10.344) stroke#fff stroke-miterlimit10 stroke-width2.264 opacity0.5/> path dM9.419,76.036A101.025,101.025,0,1,1,80.855,199.767,101.026,101.026,0,0,1,9.419,76.036Z transformtranslate(7.109 0.342) stroke#fff stroke-miterlimit10 stroke-width2.264 opacity0.5/> circle cx101.026 cy101.026 r101.026 transformmatrix(0.996, -0.085, 0.085, 0.996, 0, 17.271) stroke#fff stroke-miterlimit10 stroke-width2.264 opacity0.5/> path dM105.442,200.4A93.358,93.358,0,1,0,12.085,107.04,93.357,93.357,0,0,0,105.442,200.4 transformtranslate(7.109 0.342)/> /g> /svg> div classstat__content> span classstat__number>800/span> p>patients treated*/p> /div>/div> div data-component-idelevidys_barrio:statistic classstat> svg xmlnshttp://www.w3.org/2000/svg fill#425cc7 viewbox0 0 221.034 221.033> g transformtranslate(1.225 1.225)> circle cx101.026 cy101.026 r101.026 transformtranslate(15.291 10.344) stroke#fff stroke-miterlimit10 stroke-width2.264 opacity0.5/> path dM9.419,76.036A101.025,101.025,0,1,1,80.855,199.767,101.026,101.026,0,0,1,9.419,76.036Z transformtranslate(7.109 0.342) stroke#fff stroke-miterlimit10 stroke-width2.264 opacity0.5/> circle cx101.026 cy101.026 r101.026 transformmatrix(0.996, -0.085, 0.085, 0.996, 0, 17.271) stroke#fff stroke-miterlimit10 stroke-width2.264 opacity0.5/> path dM105.442,200.4A93.358,93.358,0,1,0,12.085,107.04,93.357,93.357,0,0,0,105.442,200.4 transformtranslate(7.109 0.342)/> /g> /svg> div classstat__content> span classstat__number>70/span> p>treatment centers/p> /div>/div> /div> /div> div classparagraph paragraph--type--text paragraph--view-mode--default> div data-component-idelevidys_barrio:text> p classtext-align-center>span classh5>A path forward for patients with Duchennesup>1/sup>/span>/p>ul>li>Statistically significant and highly expressed ELEVIDYS micro-dystrophin/li>li>Clinically relevant impact on motor function in ambulatory patients/li>li>Consistent safety results across more than 150 clinical trial patients; limited safety information in non-ambulatory patients/li>li>One-time outpatient gene therapysup>†/sup>/li>/ul>p classtext-align-center footnote>* Includes worldwide clinical trial and US commercial use through March 2025.br>† Setting must support monitoring of potential infusion-related reactions during and up to 3 hours after infusion including the ability to immediately treat any potential reaction./p>/div> /div> /div> /div> /div> /div> /div> /div>/div> div classfield__item> div classparagraph paragraph--type--section paragraph--view-mode--default> div classsection-layout> div classjustify-content-center layout> div classlayout--2-x-2-grid container container--narrow> div classjustify-self-center layout__region layout__region--col1> div classparagraph paragraph--type--icon-with-text paragraph--view-mode--default> section classicon-with-text--container icon-with-text--vertical> div classicon-with-text> div classicon-with-text__image> picture> source srcset/sites/elevidyshcp/files/styles/x_large_1200/public/2024-09/icon-clinical-trial-results.png.webp?itokEGVsI8ne 1x, /sites/elevidyshcp/files/styles/2x_large_1400/public/2024-09/icon-clinical-trial-results.png.webp?itokZJlnDXZX 2x mediaall and (min-width: 1200px) typeimage/webp width99 height93/> source srcset/sites/elevidyshcp/files/styles/large_992/public/2024-09/icon-clinical-trial-results.png.webp?itokaCtUK4wF 1x, /sites/elevidyshcp/files/styles/x_large_1200/public/2024-09/icon-clinical-trial-results.png.webp?itokEGVsI8ne 2x mediaall and (min-width: 992px) typeimage/webp width99 height93/> source srcset/sites/elevidyshcp/files/2024-09/icon-clinical-trial-results.png 2x mediaall and (min-width: 768px) typeimage/png width99 height93/> source srcset/sites/elevidyshcp/files/styles/medium_768/public/2024-09/icon-clinical-trial-results.png.webp?itok74Yvbu2M 2x typeimage/webp width99 height93/> img src/sites/elevidyshcp/files/styles/small_480/public/2024-09/icon-clinical-trial-results.png.webp?itok3bypwzCT altView clinical trial results /> /picture> /div> div classicon-with-text__content> h5 classtext-align-center>Clinical trial results/h5>p classtext-align-center>Meaningful treatment benefit in ambulatory patientssup>1/sup>/p> /div> footer classicon-with-text__footer> a 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classicon-with-text__image> picture> source srcset/sites/elevidyshcp/files/styles/x_large_1200/public/2024-04/icon-patient-elegibility.png.webp?itokVfwoXCR1 1x, /sites/elevidyshcp/files/styles/2x_large_1400/public/2024-04/icon-patient-elegibility.png.webp?itokK-hKZw9p 2x mediaall and (min-width: 1200px) typeimage/webp width206 height180/> source srcset/sites/elevidyshcp/files/styles/large_992/public/2024-04/icon-patient-elegibility.png.webp?itokz-wtxFCO 1x, /sites/elevidyshcp/files/styles/x_large_1200/public/2024-04/icon-patient-elegibility.png.webp?itokVfwoXCR1 2x mediaall and (min-width: 992px) typeimage/webp width206 height180/> source srcset/sites/elevidyshcp/files/2024-04/icon-patient-elegibility.png 2x mediaall and (min-width: 768px) typeimage/png width206 height180/> source srcset/sites/elevidyshcp/files/styles/medium_768/public/2024-04/icon-patient-elegibility.png.webp?itokb3HJhwR5 2x typeimage/webp width206 height180/> img src/sites/elevidyshcp/files/styles/small_480/public/2024-04/icon-patient-elegibility.png.webp?itokrJl9hyyr altLearn more about patient eligiblity /> /picture> /div> div classicon-with-text__content> h5 classtext-align-center>Patient eligibility/h5>p classtext-align-center>Genetic and anti-AAVrh74 antibody testing are required to confirm eligibilitysup>1/sup>/p> /div> footer classicon-with-text__footer> a classicon-with-text__link href/treatment-process/eligibility >Learn more →/a> /footer> /div>/section> /div> /div> div classjustify-self-center layout__region layout__region--col4> div classparagraph paragraph--type--icon-with-text paragraph--view-mode--default> section classicon-with-text--container icon-with-text--vertical> div classicon-with-text> div classicon-with-text__image> picture> source srcset/sites/elevidyshcp/files/styles/x_large_1200/public/2024-09/icon-enrollment-form_0.png.webp?itok1KV1zykD 1x, /sites/elevidyshcp/files/styles/2x_large_1400/public/2024-09/icon-enrollment-form_0.png.webp?itokxuOldIA3 2x mediaall and (min-width: 1200px) typeimage/webp width104 height119/> source srcset/sites/elevidyshcp/files/styles/large_992/public/2024-09/icon-enrollment-form_0.png.webp?itok37xdZOqz 1x, /sites/elevidyshcp/files/styles/x_large_1200/public/2024-09/icon-enrollment-form_0.png.webp?itok1KV1zykD 2x mediaall and (min-width: 992px) typeimage/webp width104 height119/> source srcset/sites/elevidyshcp/files/2024-09/icon-enrollment-form_0.png 2x mediaall and (min-width: 768px) typeimage/png width104 height119/> source srcset/sites/elevidyshcp/files/styles/medium_768/public/2024-09/icon-enrollment-form_0.png.webp?itokJfTmHetI 2x typeimage/webp width104 height119/> img src/sites/elevidyshcp/files/styles/small_480/public/2024-09/icon-enrollment-form_0.png.webp?itok2YCaoMHN altDownload the Sarepta Gene Therapy Enrollment Form /> /picture> /div> div classicon-with-text__content> h5 classtext-align-center>Sarepta Gene Therapy Enrollmentspan> /span>Form/h5>p classtext-align-center>An enrollment form is required to initiate therapy with ELEVIDYS/p> /div> footer classicon-with-text__footer> a classicon-with-text__link href/downloads/Sarepta_Gene_Therapy_Enrollment_Form.pdf target_blank>Download →/a> /footer> /div>/section> /div> /div> /div> /div> /div> /div>/div> /div> /div>/article> /div> /div> /section> /main> /div> /div> div idreferences> div classcontainer> h2>strong>References:/strong>/h2>ul>li>strong>1./strong> ELEVIDYS. Prescribing information. Sarepta Therapeutics, Inc; August 2024./li>li>strong>2./strong> Data on file. Sarepta Therapeutics, Inc. Cambridge, MA./li>/ul> /div> /div> div classsafety> section classregion region-safety> div classregion region-safety sticky-drawer-wrapper data-component-idsafety:safety idisi> div classsticky-drawer> div classcontainer position-relative> div classsafety__indication> div classviews-element-container block block-views block-views-blocksafety-safety-indications-block idblock-safety-indications-block> div classcontent> div>div classview view-safety view-id-safety view-display-id-safety_indications_block js-view-dom-id-2042f3f7105e9e4126257d4f5707fd8294348840082953036ce377e5736678d3> div classview-header> h2>Indication/h2> /div> div classview-content row> div classviews-row> div classviews-field views-field-description__value>span classfield-content>p>ELEVIDYS is indicated for the treatment of Duchenne muscular dystrophy (DMD) in individuals at least 4 years of age:/p>ul>li>For patients who are ambulatory and have a confirmed mutation in the em>DMD/em> gene/li>li>For patients who are non-ambulatory and have a confirmed mutation in the em>DMD/em> gene./li>/ul>p>The DMD indication in non-ambulatory patients is approved under accelerated approval based on expression of ELEVIDYS micro-dystrophin (noted hereafter as “micro-dystrophin”) in skeletal muscle. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s)./p>p> /p>/span>/div> /div> /div> /div>/div> /div> /div> /div> div classsafety__isi> div classviews-element-container block block-views block-views-blocksafety-safety-isi-block idblock-safety-isi-block> div classcontent> div>div classview view-safety view-id-safety view-display-id-safety_isi_block js-view-dom-id-127bcd4b4b8eb41f6e31413d9da15cad6650eb4325dd4e59ceaf056d3f510120> div classview-content row> div classviews-row> div classviews-field views-field-description__value>span classfield-content>h2>Important Safety Information/h2>p>span classcolor--primary>strong>u>CONTRAINDICATION:/u>/strong>/span>br>ELEVIDYS is contraindicated in patients with any deletion in exon 8 and/or exon 9 in the em>DMD/em> gene./p>p>span classcolor--primary>strong>u>WARNINGS AND PRECAUTIONS:/u>/strong>/span>br>span classcolor--primary>strong>Infusion-related Reactions:/strong>/span>/p>ul>li>Infusion-related reactions, including hypersensitivity reactions and anaphylaxis, have occurred during or up to several hours following ELEVIDYS administration. Closely monitor patients during administration and for at least 3 hours after the end of infusion. If symptoms of infusion-related reactions occur, slow or stop the infusion and give appropriate treatment. Once symptoms resolve, the infusion may be restarted at a lower rate./li>li>ELEVIDYS should be administered in a setting where treatment for infusion-related reactions is immediately available./li>li>Discontinue infusion for anaphylaxis. /li>/ul>p>span classcolor--primary>strong>Acute Serious Liver Injury:/strong>/span>/p>ul>li>Acute serious liver injury has been observed with ELEVIDYS, and administration may result in elevations of liver enzymes (such as GGT, GLDH, ALT, AST) or total bilirubin, typically seen within 8 weeks./li>li>Patients with preexisting liver impairment, chronic hepatic condition, or acute liver disease (eg, acute hepatic viral infection) may be at higher risk of acute serious liver injury. Postpone ELEVIDYS administration in patients with acute liver disease until resolved or controlled./li>li>Prior to ELEVIDYS administration, perform liver enzyme test and monitor liver function (clinical exam, GGT, and total bilirubin) weekly for the first 3 months following ELEVIDYS infusion. Continue monitoring if clinically indicated, until results are unremarkable (normal clinical exam, GGT, and total bilirubin levels return to near baseline levels)./li>li>Systemic corticosteroid treatment is recommended for patients before and after ELEVIDYS infusion. Adjust corticosteroid regimen when indicated. If acute serious liver injury is suspected, consultation with a specialist is recommended./li>/ul>p>span classcolor--primary>strong>Immune-mediated Myositis:/strong>/span>/p>ul>li>In clinical trials, immune-mediated myositis has been observed approximately 1 month following ELEVIDYS infusion in patients with deletion mutations involving exon 8 and/or exon 9 in the em>DMD/em> gene. Symptoms of severe muscle weakness, including dysphagia, dyspnea, and hypophonia, were observed./li>li>Limited data are available for ELEVIDYS treatment in patients with mutations in the em>DMD/em> gene in exons 1 to 17 and/or exons 59 to 71. Patients with deletions in these regions may be at risk for a severe immune-mediated myositis reaction./li>li>Advise patients to contact a physician immediately if they experience any unexplained increased muscle pain, tenderness, or weakness, including dysphagia, dyspnea, or hypophonia, as these may be symptoms of myositis. Consider additional immunomodulatory treatment (immunosuppressants eg, calcineurin-inhibitor in addition to corticosteroids) based on patient’s clinical presentation and medical history if these symptoms occur./li>/ul>p>span classcolor--primary>strong>Myocarditis:/strong>/span>/p>ul>li>Acute serious myocarditis and troponin-I elevations have been observed following ELEVIDYS infusion in clinical trials./li>li>If a patient experiences myocarditis, those with pre-existing left ventricle ejection fraction (LVEF) impairment may be at higher risk of adverse outcomes. Monitor troponin-I before ELEVIDYS infusion and weekly for the first month following infusion and continue monitoring if clinically indicated. More frequent monitoring may be warranted in the presence of cardiac symptoms, such as chest pain or shortness of breath./li>li>Advise patients to contact a physician immediately if they experience cardiac symptoms./li>/ul>p>span classcolor--primary>strong>Preexisting Immunity against AAVrh74:/strong>/span>/p>ul>li>In AAV-vector based gene therapies, preexisting anti-AAV antibodies may impede transgene expression at desired therapeutic levels. Following treatment with ELEVIDYS, all patients developed anti-AAVrh74 antibodies./li>li>Perform baseline testing for presence of anti-AAVrh74 total binding antibodies prior to ELEVIDYS administration./li>li>ELEVIDYS administration is not recommended in patients with elevated anti-AAVrh74 total binding antibody titers greater than or equal to 1:400./li>/ul>p>span classcolor--primary>strong>Adverse Reactions:/strong>/span>/p>ul>li>The most common adverse reactions (incidence ≥5%) reported in clinical studies were vomiting, nausea, liver injury, pyrexia, and thrombocytopenia./li>/ul>p>Report negative side effects of prescription drugs to the FDA. Visit a hrefhttps://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program>www.fda.gov/medwatch/a> or call a hreftel:18003321088>1-800-FDA-1088/a>. 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