{"id":464,"date":"2026-08-28T06:56:05","date_gmt":"2026-08-28T06:56:05","guid":{"rendered":"https:\/\/nhdbio.com\/elamipretide-barth-syndrome-trial-fda-accelerated-approval\/"},"modified":"2026-10-01T14:53:42","modified_gmt":"2026-10-01T14:53:42","slug":"essai-clinique-sur-lelamipreotide-dans-le-syndrome-de-barth-autorisation-acceleree-de-la-fda","status":"publish","type":"post","link":"https:\/\/nhdbio.com\/fr\/elamipretide-barth-syndrome-trial-fda-accelerated-approval\/","title":{"rendered":"Elamipr\u00e9tide dans le syndrome de Barth\u00a0: ce que montrent l'essai sur les patients 12 et le dossier FDA"},"content":{"rendered":"
Elamipretide dispose d\u00e9sormais d'un produit fini approuv\u00e9 par FDA pour une indication \u00e9troite du syndrome de Barth, mais l'approbation repose sur un ensemble de donn\u00e9es inhabituel sur une maladie rare. La partie randomis\u00e9e incluait des participants 12 et n'atteignait pas ses deux crit\u00e8res d'\u00e9valuation principaux.<\/p>
Ce que montre le dossier<\/h2>
Tous les participants randomis\u00e9s 12 \u00e9taient des hommes, \u00e2g\u00e9s de 12 \u00e0 35, sur un site US.<\/li>
L\u2019essai randomis\u00e9 n\u2019a pas montr\u00e9 de sup\u00e9riorit\u00e9 sur ses crit\u00e8res d\u2019\u00e9valuation principaux 6-minute de marche ou de fatigue.<\/li>
FDA a obtenu une approbation acc\u00e9l\u00e9r\u00e9e bas\u00e9e sur la force des extenseurs du genou observ\u00e9e au cours d'un suivi ouvert plus long et a n\u00e9cessit\u00e9 un essai de confirmation.<\/li><\/ul><\/div><\/div>Illustration \u00e9ditoriale originale du contexte de recherche. Il ne s'agit pas d'une figure d'\u00e9tude, d'une image de patient, d'une photographie du produit fourni ou d'une repr\u00e9sentation du mat\u00e9riel d'essai.<\/figcaption><\/figure>
Dossier d'\u00e9tudes<\/h2>
L'\u00e9tude crois\u00e9e a compar\u00e9 des p\u00e9riodes de 12 semaines d'\u00e9lamipr\u00e9tide et de placebo, s\u00e9par\u00e9es par un sevrage. Dix participants sont entr\u00e9s dans la prolongation ouverte et huit ont \u00e9t\u00e9 suivis jusqu\u2019\u00e0 la semaine 168.<\/p>
Population randomis\u00e9e<\/strong>Patients atteints du syndrome de Barth g\u00e9n\u00e9tiquement confirm\u00e9 12<\/span><\/div>
Crit\u00e8res d'\u00e9valuation principaux<\/strong>Distance de marche 6 en minutes et score de fatigue total<\/span><\/div>
R\u00e9sultat principal<\/strong>Aucun des deux crit\u00e8res d'\u00e9valuation n'a \u00e9t\u00e9 atteint dans la partie crois\u00e9e randomis\u00e9e<\/span><\/div>
Date d'approbation<\/strong>Septembre 19, 2025<\/span><\/div>
Type d'approbation<\/strong>Acc\u00e9l\u00e9r\u00e9; essai de confirmation requis<\/span><\/div><\/div><\/div>
R\u00e9sultats en contexte<\/h2>
FDA rapporte une force m\u00e9diane d\u2019extenseur du genou de base de newtons 124. Les changements m\u00e9dians au cours de la semaine 12 \u00e9taient de \u22125 newtons sous placebo et de +4 sous \u00e9lamipr\u00e9tide\u00a0; des changements descriptifs plus importants sont apparus au cours de la prolongation en ouvert, notamment +63 newtons parmi huit participants au cours de la semaine 168.<\/p>
Le changement ouvert est vuln\u00e9rable aux effets du temps, aux attentes, \u00e0 la poursuite s\u00e9lective et \u00e0 l\u2019absence de contr\u00f4le concurrent. FDA n\u00e9cessitait donc une confirmation post-approbation que le changement de force se traduisait par un b\u00e9n\u00e9fice pour le patient.<\/p>
Ce \u00e0 quoi cette \u00e9tude ne peut pas r\u00e9pondre<\/h2>
L'ensemble de donn\u00e9es est extr\u00eamement petit et ne peut pas prendre en charge l'analyse de sous-groupes.<\/p>
L'approbation s'applique \u00e0 Forzinity pour les patients atteints du syndrome de Barth pesant au moins 30 kg, et non aux mat\u00e9riaux g\u00e9n\u00e9riques \u00ab SS-31 \u00bb ou \u00e0 d'autres utilisations.<\/p>","protected":false},"excerpt":{"rendered":"
Elamipretide dispose d\u00e9sormais d'un produit fini approuv\u00e9 par FDA pour une indication \u00e9troite du syndrome de Barth, mais l'approbation repose sur un ensemble de donn\u00e9es inhabituel sur une maladie rare. La partie randomis\u00e9e incluait des participants 12 et n'atteignait pas ses deux crit\u00e8res d'\u00e9valuation principaux.<\/p>","protected":false},"author":1,"featured_media":2780,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"pim_family_ids":"364","pim_article_type":"Published study case","pim_evidence_level":"Small randomized crossover trial plus FDA accelerated-approval record","pim_reviewer":"NHD evidence editorial workflow","pim_reviewed_date":"2026-08-28","pim_editorial_note":"Source-checked on 2026-08-28. Null findings and study limitations are retained. This is not independent peer review, medical advice, a customer case, or validation of a catalog lot.","pim_review_status":"reviewed","pim_review_reason":"At least two linked primary or authoritative records and an explicit evidence boundary are present.","pim_creation_method":"The editorial workflow starts with linked peer-reviewed papers, trial registries or regulatory records; extracts the population or model, endpoints, numerical results and limitations; and separates the studied intervention from catalog material. AI-assisted drafting was used to structure the first version. Claims, figures, evidence labels and limitations were checked against the linked records in the site editorial workflow. This is not independent peer review.","pim_sources":"[{\"title\":\"FDA Drug Trials Snapshot: Forzinity\",\"url\":\"https:\/\/www.fda.gov\/drugs\/drug-trials-snapshots\/drug-trials-snapshots-forzinity\",\"note\":\"Trial population, endpoint results and approval basis.\"},{\"title\":\"Elamipretide phase 2\/3 Barth syndrome crossover trial\",\"url\":\"https:\/\/pubmed.ncbi.nlm.nih.gov\/33077895\/\",\"note\":\"Primary published trial; PMID 33077895.\"},{\"title\":\"FDA accelerated approval announcement for Forzinity\",\"url\":\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-grants-accelerated-approval-first-treatment-barth-syndrome\",\"note\":\"Approval scope and confirmatory requirement.\"}]","footnotes":""},"categories":[19],"tags":[],"class_list":["post-464","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-published-study-cases"],"yoast_head":"\n
Elamipretide in Barth Syndrome: What the 12-Patient Trial and FDA Record Show - NHD<\/title>\n<meta name=\"description\" content=\"Elamipretide now has an FDA-approved finished product for a narrow Barth syndrome indication, but the approval rests on an unusual rare-disease dataset. Th\u2026\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/nhdbio.com\/fr\/essai-clinique-sur-lelamipreotide-dans-le-syndrome-de-barth-autorisation-acceleree-de-la-fda\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Elamipretide in Barth Syndrome: What the 12-Patient Trial and FDA Record Show\" \/>\n<meta property=\"og:description\" content=\"Elamipretide now has an FDA-approved finished product for a narrow Barth syndrome indication, but the approval rests on an unusual rare-disease dataset. 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