{"id":20004,"date":"2026-10-06T13:18:24","date_gmt":"2026-10-06T13:18:24","guid":{"rendered":"https:\/\/veilles-affaires-sociales.fr\/?p=20004"},"modified":"2026-10-06T13:18:24","modified_gmt":"2026-10-06T13:18:24","slug":"medicaments-a-usage-humain-rapport-europeen-public-devaluation-epar-myalepta-metreleptine-date-dautorisation-30-07-2018-revision-16-statut-autorise-titr","status":"publish","type":"post","link":"https:\/\/veilles-affaires-sociales.fr\/?p=20004","title":{"rendered":"M\u00e9dicaments \u00e0 usage humain \u2013 Rapport europ\u00e9en public d\u2019\u00e9valuation (EPAR) : Myalepta, m\u00e9tr\u00e9leptine, Date d\u2019autorisation : 30\/07\/2018, R\u00e9vision : 16, Statut : Autoris\u00e9\u00a0(titre traduit en fran\u00e7ais par l&rsquo;IA)"},"content":{"rendered":"<p>Myalepta est un m\u00e9dicament indiqu\u00e9 en compl\u00e9ment du r\u00e9gime alimentaire pour le traitement de certaines formes de lipodystrophie, caract\u00e9ris\u00e9es par une perte de tissu adipeux sous-cutan\u00e9 et une accumulation de graisse dans d\u2019autres organes (notamment foie et muscles). Il contient comme substance active la m\u00e9tr\u00e9leptine, analogue de l\u2019hormone humaine leptine, impliqu\u00e9e dans la r\u00e9gulation du m\u00e9tabolisme des graisses et des sucres.<\/p>\n<p>Le m\u00e9dicament est autoris\u00e9 chez l\u2019adulte et l\u2019enfant de plus de 2 ans atteints de lipodystrophie g\u00e9n\u00e9ralis\u00e9e (syndrome de Berardinelli-Seip et syndrome de Lawrence), ainsi que chez l\u2019adulte et l\u2019enfant de plus de 12 ans atteints de lipodystrophie partielle (notamment syndrome de Barraquer-Simons), lorsque les traitements standards ont \u00e9chou\u00e9. Ces maladies \u00e9tant rares, Myalepta a obtenu le statut de m\u00e9dicament orphelin au niveau europ\u00e9en le 17 juillet 2012 pour plusieurs indications (syndrome de Berardinelli-Seip, syndrome de Lawrence, lipodystrophie partielle familiale, syndrome de Barraquer-Simons). Les informations relatives \u00e0 ces d\u00e9signations sont disponibles sur le site de l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA).<\/p>\n<p>Myalepta est un m\u00e9dicament soumis \u00e0 prescription m\u00e9dicale, dont l\u2019instauration et la surveillance doivent \u00eatre assur\u00e9es par un m\u00e9decin exp\u00e9riment\u00e9 dans la prise en charge des troubles m\u00e9taboliques. Il est administr\u00e9 une fois par jour par injection sous-cutan\u00e9e (abdomen, cuisse ou bras) \u00e0 heure fixe. La posologie d\u00e9pend du poids corporel et peut \u00eatre ajust\u00e9e en fonction de la r\u00e9ponse au traitement. Apr\u00e8s formation, le patient ou un aidant peut r\u00e9aliser lui-m\u00eame l\u2019injection.<\/p>\n<p>Chez les patients atteints de lipodystrophie, les faibles taux de leptine entra\u00eenent une perte de graisse sous-cutan\u00e9e, une accumulation de graisse dans certains organes, une hypertriglyc\u00e9rid\u00e9mie et une insulinor\u00e9sistance. La m\u00e9tr\u00e9leptine remplace la leptine manquante et favorise la d\u00e9gradation des graisses dans le sang, les muscles et le foie, contribuant \u00e0 corriger certaines anomalies m\u00e9taboliques, notamment l\u2019insulinor\u00e9sistance. Le traitement ne permet toutefois pas de restaurer le tissu adipeux sous-cutan\u00e9.<\/p>\n<p>L\u2019efficacit\u00e9 de Myalepta a \u00e9t\u00e9 \u00e9valu\u00e9e dans deux \u00e9tudes principales non comparatives (sans groupe contr\u00f4le) incluant au total 107 adultes et enfants atteints de lipodystrophie g\u00e9n\u00e9ralis\u00e9e ou partielle. Apr\u00e8s 12 mois de traitement, les taux sanguins de triglyc\u00e9rides sont pass\u00e9s d\u2019environ 15 mmol\/l \u00e0 environ 5 mmol\/l chez les patients avec forme g\u00e9n\u00e9ralis\u00e9e, et d\u2019environ 16 mmol\/l \u00e0 environ 6 mmol\/l chez ceux avec forme partielle. Ces r\u00e9sultats mettent en \u00e9vidence une am\u00e9lioration marqu\u00e9e des param\u00e8tres lipidiques, mais dans le cadre d\u2019\u00e9tudes sans comparaison directe avec d\u2019autres traitements. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l&rsquo;IA)\u00a0\u200b<a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/myalepta\" target=\"_blank\" class=\"feedzy-rss-link-icon\">Lire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Myalepta est un m\u00e9dicament indiqu\u00e9 en compl\u00e9ment du r\u00e9gime alimentaire pour le traitement de certaines formes de lipodystrophie, caract\u00e9ris\u00e9es par une perte de tissu adipeux sous-cutan\u00e9 et une accumulation de [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":17698,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","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":"","ast-disable-related-posts":"","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-5)","background-image":"","background-repeat":"repeat","background-position":"center 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