{"id":5892,"date":"2024-11-04T23:27:33","date_gmt":"2024-11-04T23:27:33","guid":{"rendered":"https:\/\/tech.newat9.com\/index.php\/2024\/11\/04\/aga-urges-continued-access-to-conventional-fmt-for-c-difficile-patients\/"},"modified":"2024-11-04T23:27:33","modified_gmt":"2024-11-04T23:27:33","slug":"aga-urges-continued-access-to-conventional-fmt-for-c-difficile-patients","status":"publish","type":"post","link":"https:\/\/tech.newat9.com\/index.php\/2024\/11\/04\/aga-urges-continued-access-to-conventional-fmt-for-c-difficile-patients\/","title":{"rendered":"AGA urges continued access to conventional FMT for C. difficile patients"},"content":{"rendered":"<p> <br \/>\n<\/p>\n<div data-component=\"ArticleContent\">\n<div class=\"article__content--header\">\n<div class=\"article__posted-date\">\n<p> November 04, 2024 <\/p>\n<p> 2 min read <\/p>\n<\/div>\n<\/div>\n<div class=\"mobile-trust-box\">\n<div class=\"row\">\n<div class=\"col-12 col-md-5 d-xl-none\">\n<div class=\"trust-box\">\n<div class=\"trust-box-logo d-none d-md-block\">\n<img decoding=\"async\" src=\"https:\/\/www.healio.com\/~\/media\/h5\/feature\/news\/publogos\/hgld\/healio_gastro.svg?la=en&amp;h=40&amp;w=152&amp;hash=2C654A538F2E250F5183D42A89FE0EC0\" class=\"logo-img\" height=\"40\" alt=\"Healio Logo - Gastroenterology\" width=\"152\"\/>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"col-12 col-md-6 offset-md-1 offset-xl-0 col-xl-12\">\n<div class=\"d-none\" data-component=\"EmailTopicAlert\" data-module=\"Subspecialty Email Topic Alerts Top\" data-manage-email-link=\"\/footer\/account-information\/my-account\/email-subscriptions-and-alerts#emailAlerts\">\n<hidden data-setting-item=\"d265901d-6d37-49c7-a8f6-c7bf19a02509\"\/><br \/>\n<hidden data-crm-source=\"Subspecialty Topic Alert\"\/><\/p>\n<div class=\"email-alert-button d-none\" data-topic-button=\"not-subscribed\">\n<p>\n<span data-module-track-action=\"Email Alerts TOP_Click_Healio News Article\" data-module-track-label=\"Email Alerts TOP_Healio News Article\"><br \/>\n<i class=\"fas fa-plus-circle\"\/><br \/>\nAdd topic to email alerts<br \/>\n<\/span>\n<\/p>\n<div class=\"email-alert-inner collapse ucefe5fe940024dbcb34080bd7a837dab\">\n<div class=\"email-alert-dialogue\">\n<p>\nReceive an email when new articles are posted on <span data-content=\"topic-title\"\/>\n<\/p>\n<div class=\"d-none\" data-sign-up-type=\"unknown\">\nPlease provide your email address to receive an email when new articles are posted on <span data-content=\"topic-title\"\/>.<\/p>\n<\/div>\n<\/div>\n<p><button type=\"button\" class=\"btn btn-primary\" data-loading-text=\"Loading &lt;i class=\" fa=\"\" fa-spinner=\"\" fa-spin=\"\">&#8221; data-action=subscribe&gt;<br \/>\nSubscribe<br \/>\n<\/button>\n<\/div>\n<\/div>\n<div class=\"d-none\" data-topic-modal=\"failed\"> <strong>We were unable to process your request. Please try again later. If you continue to have this issue please contact <a href=\"https:\/\/www.healio.com\/news\/gastroenterology\/20241104\/mailto:customerservice@slackinc.com\" target=\"_blank\" rel=\"noopener\">customerservice@slackinc.com<\/a>.<\/strong> <\/p>\n<p><button data-dismiss=\"modal\" class=\"btn btn-primary btn-lg btn-block\">Back to Healio<\/button><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<p>As of Nov. 1, OpenBiome suspended its distribution of investigational fecal microbiota transplantation, which may put certain patients with recurrent, refractory or fulminant <i>Clostridioides difficile<\/i> infection at risk, according to the AGA.<\/p>\n<p>\u201cIt is important to understand that the suspension is a voluntary action on the part of OpenBiome, which is the result of some communications they have received from the FDA,\u201d AGA spokesperson <b>Colleen R. Kelly, MD<\/b><b> <\/b>co-principal investigator of the AGA\u2019s FMT National Registry and gastroenterologist at Brigham and Women\u2019s Hospital, told Healio. \u201cFDA issued a guidance in November 2022, which stated that enforcement policy around <a href=\"https:\/\/www.healio.com\/news\/gastroenterology\/20231009\/fecal-transplant-not-over-yet-for-c-difficile-despite-boom-in-live-microbiota-therapies\" id=\"rId11\" target=\"_blank\" rel=\"noopener\">investigational new drug applications for FMT<\/a> would no longer be extended to \u2018stool banks.\u2019\u201d<\/p>\n<figure class=\"figure article__og-image\">\n<picture><source srcset=\"https:\/\/www.healio.comhttps:\/\/www.healio.comhttps:\/\/www.healio.com\/~\/media\/slack-news\/gastroenterology\/misc\/infographics\/2024\/1124\/hgi1124aga_fmtletter_graphic_01.webp?w=476\" media=\"(max-width: 768px)\"><source srcset=\"https:\/\/www.healio.com\/~\/media\/slack-news\/gastroenterology\/misc\/infographics\/2024\/1124\/hgi1124aga_fmtletter_graphic_01.webp?w=800\" media=\"(max-width: 992px)\"><source srcset=\"https:\/\/www.healio.com\/~\/media\/slack-news\/gastroenterology\/misc\/infographics\/2024\/1124\/hgi1124aga_fmtletter_graphic_01.webp?w=595\" media=\"(max-width: 1200px)\"><source srcset=\"https:\/\/www.healio.comhttps:\/\/www.healio.comhttps:\/\/www.healio.com\/~\/media\/slack-news\/gastroenterology\/misc\/infographics\/2024\/1124\/hgi1124aga_fmtletter_graphic_01.webp?w=476\" media=\"(min-width: 1200px)\"><source srcset=\"https:\/\/www.healio.comhttps:\/\/www.healio.comhttps:\/\/www.healio.com\/~\/media\/slack-news\/gastroenterology\/misc\/infographics\/2024\/1124\/hgi1124aga_fmtletter_graphic_01.webp?w=476\"><img decoding=\"async\" src=\"https:\/\/www.healio.com\/~\/media\/slack-news\/gastroenterology\/misc\/infographics\/2024\/1124\/hgi1124aga_fmtletter_graphic_01.jpg?w=800\" alt=\"&quot;[If the] FDA does not continue to allow enforcement discretion for stool banks, many of these patients will lose access to FMT, and some may die.&#x201D; Colleen R. Kelly, MD\" class=\"figure-img img-fluid\" width=\"800\"\/><br \/>\n<\/source><\/source><\/source><\/source><\/source><\/picture><figcaption class=\"figure-caption\">\n<\/figcaption><\/figure>\n<p>According to an OpenBiome press release, the FDA allowed the nonprofit organization to continue shipment of investigational FMT produced by the University of Minnesota through Oct. 31, 2024, during which time OpenBiome would accelerate its timeline for an IND submission.<\/p>\n<p>Kelly noted that <a href=\"https:\/\/www.healio.com\/news\/gastroenterology\/20170112\/onsite-with-openbiome\" id=\"rId12\" target=\"_blank\" rel=\"noopener\">OpenBiome<\/a> has spent \u201cover a year\u201d trying to find a solution for this updated policy, including through the FDA\u2019s Real World Evidence Program. <\/p>\n<p>With no solution in sight, the AGA, in collaboration with the Infectious Diseases Society of America, NASPGHAN, the Crohn\u2019s and Colitis Foundation and the Peggy Lillis Foundation, sent a letter to <b>Peter Marks, MD, PhD<\/b>, head of the FDA\u2019s Center for Biologics Evaluation and Research, urging the agency to \u201cretain an enforcement policy that would preserve access to FMT\u201d for patients for whom currently approved therapies are not indicated or are ineffective or difficult to access. <\/p>\n<p>In addition, the organizations requested the opportunity to meet with FDA representatives to discuss current evidence, recommendations and clinical practice trends related to FMT.<\/p>\n<p>\u201cWe do not currently have an <a href=\"https:\/\/www.healio.com\/news\/gastroenterology\/20231009\/fmt-future-still-being-written-ideally-with-more-options-for-recurrent-c-difficile\" id=\"rId13\" target=\"_blank\" rel=\"noopener\">FDA-approved FMT product<\/a> for severe or fulminant <i>C. difficile<\/i> or for pediatrics,\u201d Kelly said. \u201cFurthermore, there are already patients who have failed to resolve their infections with the available products. [If the] FDA does not continue to allow enforcement discretion for stool banks, many of these patients will lose access to FMT and some may die.\u201d<\/p>\n<p>Although the letter highlighted the FDA\u2019s recent approval of <a href=\"https:\/\/www.healio.com\/news\/gastroenterology\/20221201\/fda-approves-fecal-microbiota-biotherapeutic-for-recurrent-c-difficile-infection\" id=\"rId14\" target=\"_blank\" rel=\"noopener\">Rebyota<\/a> (fecal microbiota, live-jslm; Ferring Pharmaceuticals) and <a href=\"https:\/\/www.healio.com\/news\/gastroenterology\/20230427\/fda-approves-vowst-as-first-oral-microbiota-biotherapeutic-for-recurrent-c-difficile\" id=\"rId15\" target=\"_blank\" rel=\"noopener\">Vowst<\/a> (fecal microbiota spores, live-brpk; Nestl\u00e9 Health Science\/Seres Therapeutics) for prevention of recurrent <i>C. difficile<\/i> infection in adult patients who have completed antibiotic therapy, the authors noted that recurrent, refractory and fulminant infections \u201ccontinue to pose a challenge\u201d for clinicians and patients. For this reason, conventional FMT from known donors or stool banks remains an \u201cessential, safe and effective\u201d therapeutic option, they wrote.<\/p>\n<p>\u201cThe currently approved FMT therapeutics largely excluded immunocompromised patients from their clinical trials, so it is unknown how effective or safe these will be in this population,\u201d Kelly told Healio. \u201cAGA published <a href=\"https:\/\/www.healio.com\/news\/gastroenterology\/20240221\/aga-guideline-endorses-fmt-for-recurrent-c-difficile-not-yet-advised-for-ibs-ibd\" id=\"rId16\" target=\"_blank\" rel=\"noopener\">FMT guidelines earlier this year<\/a> that recommended \u2018conventional FMT\u2019 rather than either Rebyota or Vowst for these patients. These formulations are also much more expensive, and depending on the type of insurance a patient has, may cost thousands of dollars per dose or treatment course.\u201d<\/p>\n<p>According to Kelly, the AGA also will continue to support the FMT National Patient Registry to generate real-world data on the procedure\u2019s safety and efficacy and will intensify efforts to enroll patients with severe and fulminant infections.<\/p>\n<h2>References:<\/h2>\n<div class=\"article__content--footer\">\n<div class=\"publisher-logo\">\n<span>Published by:<\/span><br \/>\n<img decoding=\"async\" src=\"https:\/\/www.healio.com\/~\/media\/h5\/feature\/news\/publogos\/hgld\/healio_gastro.svg?la=en&amp;h=40&amp;w=152&amp;hash=2C654A538F2E250F5183D42A89FE0EC0\" class=\"logo-img\" height=\"40\" alt=\"Healio Logo - Gastroenterology\" width=\"152\"\/>\n<\/div>\n<div class=\"d-none\" data-component=\"EmailTopicAlert\" data-module=\"Subspecialty Email Topic Alerts Top\" data-manage-email-link=\"\/footer\/account-information\/my-account\/email-subscriptions-and-alerts#emailAlerts\">\n<hidden data-setting-item=\"d265901d-6d37-49c7-a8f6-c7bf19a02509\"\/><br \/>\n<hidden data-crm-source=\"Subspecialty Topic Alert\"\/><\/p>\n<div class=\"email-alert-button d-none\" data-topic-button=\"not-subscribed\">\n<p>\n<span data-module-track-action=\"Email Alerts TOP_Click_Healio News Article\" data-module-track-label=\"Email Alerts TOP_Healio News Article\"><br \/>\n<i class=\"fas fa-plus-circle\"\/><br \/>\nAdd topic to email alerts<br \/>\n<\/span>\n<\/p>\n<div class=\"email-alert-inner collapse ucefe5fe940024dbcb34080bd7a837dab\">\n<div class=\"email-alert-dialogue\">\n<p>\nReceive an email when new articles are posted on <span data-content=\"topic-title\"\/>\n<\/p>\n<div class=\"d-none\" data-sign-up-type=\"unknown\">\nPlease provide your email address to receive an email when new articles are posted on <span data-content=\"topic-title\"\/>.<\/p>\n<\/div>\n<\/div>\n<p><button type=\"button\" class=\"btn btn-primary\" data-loading-text=\"Loading &lt;i class=\" fa=\"\" fa-spinner=\"\" fa-spin=\"\">&#8221; data-action=subscribe&gt;<br \/>\nSubscribe<br \/>\n<\/button>\n<\/div>\n<\/div>\n<div class=\"d-none\" data-topic-modal=\"failed\"> <strong>We were unable to process your request. 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If you continue to have this issue please contact <a href=\"https:\/\/www.healio.com\/news\/gastroenterology\/20241104\/mailto:customerservice@slackinc.com\" target=\"_blank\" rel=\"noopener\">customerservice@slackinc.com<\/a>.<\/strong> <\/p>\n<p><button data-dismiss=\"modal\" class=\"btn btn-primary btn-lg btn-block\">Back to Healio<\/button><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<p><br \/>\n<br \/><a href=\"https:\/\/www.healio.com\/news\/gastroenterology\/20241104\/some-may-die-aga-urges-continued-access-to-conventional-fmt-for-c-difficile-patients\" target=\"_blank\" rel=\"noopener\">Source link <\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>November 04, 2024 2 min read Add topic to email alerts Receive an email when new articles are posted on [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":5893,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[1],"tags":[],"_links":{"self":[{"href":"https:\/\/tech.newat9.com\/index.php\/wp-json\/wp\/v2\/posts\/5892"}],"collection":[{"href":"https:\/\/tech.newat9.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/tech.newat9.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/tech.newat9.com\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/tech.newat9.com\/index.php\/wp-json\/wp\/v2\/comments?post=5892"}],"version-history":[{"count":0,"href":"https:\/\/tech.newat9.com\/index.php\/wp-json\/wp\/v2\/posts\/5892\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/tech.newat9.com\/index.php\/wp-json\/wp\/v2\/media\/5893"}],"wp:attachment":[{"href":"https:\/\/tech.newat9.com\/index.php\/wp-json\/wp\/v2\/media?parent=5892"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/tech.newat9.com\/index.php\/wp-json\/wp\/v2\/categories?post=5892"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/tech.newat9.com\/index.php\/wp-json\/wp\/v2\/tags?post=5892"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}