{"id":34174,"date":"2022-01-15T08:00:00","date_gmt":"2022-01-15T07:00:00","guid":{"rendered":"https:\/\/d3glparxwv1yl3.cloudfront.net\/press-releases\/sante-canada-approuve-le-medicament-sohonos-dipsen-capsules-de-palovarotene-qui-devient-le-premier-traitement-approuve-contre-la-fibrodysplasie-ossifiante-progressive\/"},"modified":"2022-01-15T08:00:00","modified_gmt":"2022-01-15T07:00:00","slug":"sante-canada-approuve-le-medicament-sohonos-dipsen-capsules-de-palovarotene-qui-devient-le-premier-traitement-approuve-contre-la-fibrodysplasie-ossifiante-progressive","status":"publish","type":"press_release","link":"https:\/\/d3glparxwv1yl3.cloudfront.net\/fr\/press-releases\/sante-canada-approuve-le-medicament-sohonos-dipsen-capsules-de-palovarotene-qui-devient-le-premier-traitement-approuve-contre-la-fibrodysplasie-ossifiante-progressive\/","title":{"rendered":"Sant\u00e9 Canada approuve le m\u00e9dicament Sohonos d\u2019Ipsen (capsules de palovarot\u00e8ne) qui devient le premier traitement approuv\u00e9 contre la fibrodysplasie ossifiante progressive"},"content":{"rendered":"<p> <\/p>\n<p><b>PARIS, France, 24 janvier 2022 \u2013\u00a0<\/b>Ipsen (Euronext : IPN ; ADR : IPSEY) a annonc\u00e9 aujourd\u2019hui l\u2019approbation par Sant\u00e9 Canada de Sohonos (capsules de palovarot\u00e8ne), un agoniste s\u00e9lectif du r\u00e9cepteur gamma de l\u2019acide r\u00e9tino\u00efque (RAR\u03b3) administr\u00e9 par voie orale, indiqu\u00e9 pour diminuer la formation d\u2019ossification h\u00e9t\u00e9rotopique (OH ; formation d\u2019os) chez l\u2019adulte et l\u2019enfant (filles de 8 ans et plus, gar\u00e7ons de 10 ans et plus) atteints de fibrodysplasie ossifiante progressive (FOP).1\u00a0Sohonos a \u00e9t\u00e9 approuv\u00e9 comme traitement de fond et des pouss\u00e9es chez les patients atteints de FOP. Cette d\u00e9cision marque la premi\u00e8re approbation de Sohonos dans le monde.<\/p>\n<p><b>Le Docteur Howard Mayer, Vice-Pr\u00e9sident ex\u00e9cutif, Directeur de la Recherche et du D\u00e9veloppement, Ipsen,\u00a0<\/b>a d\u00e9clar\u00e9\u00a0: \u00ab\u00a0<em>La FOP est une maladie progressive et invalidante qui affecte profond\u00e9ment les patients et leurs familles.<\/em>\u00a0<em>Jusqu\u2019\u00e0 ce jour, aucun m\u00e9dicament n\u2019\u00e9tait approuv\u00e9. Nous sommes fiers de fournir ce nouveau m\u00e9dicament important \u00e0 la communaut\u00e9 FOP.\u00a0<\/em>\u00bb<\/p>\n<p>La FOP se caract\u00e9rise par une nouvelle formation osseuse en dehors du syst\u00e8me squelettique normal, comme dans les tissus conjonctifs mous ; un processus connu sous le nom d\u2019ossification h\u00e9t\u00e9rotopique,\u00a02qui peut \u00eatre pr\u00e9c\u00e9d\u00e9 d\u2019un gonflement douloureux des tissus mous ou \u00ab pouss\u00e9es \u00bb2. Les pouss\u00e9es sont fr\u00e9quentes et contribuent de mani\u00e8re substantielle \u00e0 la formation de nouvelle mati\u00e8re osseuse, mais la mati\u00e8re osseuse peut \u00e9galement se former en l\u2019absence de pouss\u00e9e. Une fois form\u00e9e, elle est irr\u00e9versible et entra\u00eene une perte de mobilit\u00e9 ainsi qu\u2019une esp\u00e9rance de vie r\u00e9duite2. Il s\u2019agit d\u2019une maladie g\u00e9n\u00e9tique ultra-rare, dont la pr\u00e9valence est estim\u00e9e \u00e0 1,36 personne sur 1 million ; cependant, le nombre de cas confirm\u00e9s varie selon les pays3,4.<\/p>\n<p>Dans le cadre de son engagement continu envers la communaut\u00e9 de la FOP et des maladies rares, Ipsen envisage de d\u00e9poser une demande aux \u00c9tats-Unis au premier semestre 2022 et est actuellement en discussion avec d\u2019autres autorit\u00e9s r\u00e9glementaires \u00e0 travers le monde.<\/p>\n<p> <\/p>\n<ol>\n<li style=\"margin-bottom:3px\">Data on file<\/li>\n<li style=\"margin-bottom:3px\">Kaplan FS, et al. The medical management of fibrodysplasia ossificans progressiva: current treatment considerations. Proc Intl Clin Council FOP 1:1-111, 2019.<\/li>\n<li style=\"margin-bottom:3px\">Lilijesthrom, M &amp; Bogard, B 2016, \u2018The global known FOP population\u2019, FOP Drug Development Forum, Boston, MA, 24-25 October.<\/li>\n<li style=\"margin-bottom:3px\">Baujat et al. Prevalence of fibrodysplasia ossificans progressiva (FOP) in France: an estimate based on a record linkage of two national databases. Orphanet Journal of Rare Diseases. 2017; 12:123.<\/li>\n<\/ol>\n<p id=\"gnw_attachments_section-header\">\n    <strong>Pi\u00e8ce jointe<\/strong>\n<\/p>\n<ul id=\"gnw_attachments_section-items\">\n<li>\n        <a target=\"_blank\" href=\"https:\/\/www.globenewswire.com\/Tracker?data=GneksC1I1FziAMlt5V40qR6r9t8ooXCQl3iia2tqieHxutwQdY4WinA7PH913RXY-jCOx20rEkIPhxfJI-np6tzRzYrcUxIQdeUO7R1P8vbx6fzCpkGObmAbAYqVcTzZNSrDiqlj9lhEdvlf8TBNIKdAuapIl1Tdz9E_GGvyQ-F3_SGNZxKPD90SeRuzVeLaCpHQbC6lMT7IkGdEd5lgBWr4p5VUiPutZMdoBXJNg75uuR873vsuh7iyN7jpiALs4HxFiLCBidqZT6neb4YGuA==\" title=\"Ipsen-Sante-Canada-approuve-le-medicament-Sohonos-dIpsen-capsules-de-palovarotene-24-Janvier-2022\" rel=\"nofollow noopener\">Ipsen-Sante-Canada-approuve-le-medicament-Sohonos-dIpsen-capsules-de-palovarotene-24-Janvier-2022<\/a>\n      <\/li>\n<\/ul>\n<p><img src='https:\/\/ml-eu.globenewswire.com\/media\/ODNjMmE0YzEtZTVkNS00NTQwLTg4YjEtODZkNmNlMmJmNDVkLTEwMTA5NDM=\/tiny\/Ipsen-SA.png' \/><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"template":"","categories":[3563],"tags":[],"class_list":["post-34174","press_release","type-press_release","status-publish","hentry","category-rare-diseases-pressrelease-fr","entry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.5 - 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