{"id":21272,"date":"2026-10-16T10:01:07","date_gmt":"2026-10-16T10:01:07","guid":{"rendered":"https:\/\/veilles-affaires-sociales.fr\/?p=21272"},"modified":"2026-10-16T10:01:07","modified_gmt":"2026-10-16T10:01:07","slug":"rapport-europeen-public-devaluation-epar-des-medicaments-a-usage-humain-foundayo-orforglipron-statut-avis-titre-traduit-en-francais-par-lia","status":"publish","type":"post","link":"https:\/\/veilles-affaires-sociales.fr\/?p=21272","title":{"rendered":"Rapport europ\u00e9en public d\u2019\u00e9valuation (EPAR) des m\u00e9dicaments \u00e0 usage humain : Foundayo, Orforglipron, Statut : Avis\u00a0(titre traduit en fran\u00e7ais par l&rsquo;IA)"},"content":{"rendered":"<p>Le 15 octobre 2026, le Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP) de l\u2019Agence europ\u00e9enne des m\u00e9dicaments a adopt\u00e9 un avis favorable recommandant l\u2019octroi d\u2019une autorisation de mise sur le march\u00e9 pour Foundayo, un m\u00e9dicament destin\u00e9 au traitement du diab\u00e8te de type 2 et \u00e0 la prise en charge du poids. Le demandeur est la soci\u00e9t\u00e9 Eli Lilly Nederland B.V. L\u2019autorisation devra encore \u00eatre formellement d\u00e9livr\u00e9e par la Commission europ\u00e9enne, apr\u00e8s quoi le r\u00e9sum\u00e9 des caract\u00e9ristiques du produit (RCP) sera publi\u00e9 sur le site de l\u2019EMA dans toutes les langues officielles de l\u2019Union europ\u00e9enne.<\/p>\n<p>Foundayo sera disponible sous forme de comprim\u00e9s pellicul\u00e9s de 0,8 mg, 2,5 mg, 5,5 mg, 9 mg, 14,5 mg et 17,2 mg. La substance active est l\u2019orforglipron (orforglipron h\u00e9micalcium), agoniste des r\u00e9cepteurs du GLP\u20111 (glucagon-like peptide 1), class\u00e9 dans le syst\u00e8me ATC sous un code encore non attribu\u00e9. L\u2019action sur ces r\u00e9cepteurs permet une am\u00e9lioration du contr\u00f4le glyc\u00e9mique et contribue \u00e0 la gestion du poids via plusieurs m\u00e9canismes. Les effets ind\u00e9sirables les plus fr\u00e9quents sont des troubles gastro-intestinaux, notamment naus\u00e9es, vomissements et diarrh\u00e9es.<\/p>\n<p>Pour la gestion du poids, Foundayo est indiqu\u00e9 chez l\u2019adulte en compl\u00e9ment d\u2019un r\u00e9gime alimentaire sain et d\u2019une activit\u00e9 physique, pour la perte de poids et le maintien de la perte de poids, chez les personnes ayant un IMC initial \u2265 30 kg\/m\u00b2 (ob\u00e9sit\u00e9) ou un IMC entre 27 et &lt; 30 kg\/m\u00b2 (surpoids) en pr\u00e9sence d\u2019au moins une comorbidit\u00e9 li\u00e9e au poids (par exemple : pr\u00e9diab\u00e8te ou diab\u00e8te de type 2, hypertension, dyslipid\u00e9mie, apn\u00e9e obstructive du sommeil ou maladie cardiovasculaire). Pour le diab\u00e8te de type 2, Foundayo est indiqu\u00e9 chez l\u2019adulte insuffisamment contr\u00f4l\u00e9, en compl\u00e9ment d\u2019un r\u00e9gime alimentaire sain et de l\u2019activit\u00e9 physique, soit en monoth\u00e9rapie lorsque la metformine est jug\u00e9e inappropri\u00e9e, soit en association avec d\u2019autres m\u00e9dicaments antidiab\u00e9tiques. Les r\u00e9sultats d\u2019essais cliniques relatifs aux associations th\u00e9rapeutiques, aux effets cardiovasculaires, au contr\u00f4le glyc\u00e9mique et aux populations \u00e9tudi\u00e9es sont renvoy\u00e9s aux sections 4.4, 4.5 et 5.1 du futur RCP.<\/p>\n<p>Les b\u00e9n\u00e9fices mis en avant sont un effet cliniquement pertinent sur le contr\u00f4le glyc\u00e9mique chez les patients atteints de diab\u00e8te de type 2 et un effet favorable sur le poids corporel lorsqu\u2019il est utilis\u00e9 avec un r\u00e9gime et une activit\u00e9 physique. Cette d\u00e9cision du CHMP s\u2019inscrit dans le contexte europ\u00e9en de d\u00e9veloppement de nouveaux traitements oraux \u00e0 base d\u2019agonistes du GLP\u20111 pour la prise en charge conjointe de l\u2019ob\u00e9sit\u00e9, du surpoids et du diab\u00e8te de type 2, avec des implications possibles pour les politiques de sant\u00e9 publique et l\u2019organisation des prises en charge, notamment en termes de crit\u00e8res d\u2019\u00e9ligibilit\u00e9 (IMC, comorbidit\u00e9s) et d\u2019articulation avec les mesures hygi\u00e9no-di\u00e9t\u00e9tiques. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l&#039;IA)\u00a0\u200b<a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/foundayo\" target=\"_blank\" class=\"feedzy-rss-link-icon\">Lire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Le 15 octobre 2026, le Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP) de l\u2019Agence europ\u00e9enne des m\u00e9dicaments a adopt\u00e9 un avis favorable recommandant l\u2019octroi d\u2019une autorisation de mise sur le 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