{"id":5615,"date":"2022-10-03T14:31:33","date_gmt":"2022-10-03T12:31:33","guid":{"rendered":"http:\/\/www.afaf.asso.fr\/?p=5615"},"modified":"2023-01-31T20:58:25","modified_gmt":"2023-01-31T19:58:25","slug":"essai-omaveloxolone-reata-webinaire-fara-pour-comprendre","status":"publish","type":"post","link":"https:\/\/www.afaf.asso.fr\/2022\/10\/03\/essai-omaveloxolone-reata-webinaire-fara-pour-comprendre\/","title":{"rendered":"Essai sur l\u2019Omaveloxolone (REATA) : comprendre les annonces r\u00e9centes- Webinaire FARA"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"5615\" class=\"elementor elementor-5615\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-7bc45d1 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7bc45d1\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-85934c8\" data-id=\"85934c8\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-d0d7645 elementor-widget elementor-widget-text-editor\" data-id=\"d0d7645\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Cet article explique la m\u00e9thodologie de l\u2019\u00e9tude sur l&#8217;Omaveloxolone men\u00e9e par Reata (MOXIe), les r\u00e9sultats, le processus de soumission, le calendrier etc.<\/p><p><em>Compte-rendu de Cecilia Estrella sur la base du w<\/em><em>ebinaire<\/em>\u00a0de FARA a<em>vec Jen Farmer, David Lynch et Layne Rodden.\u00a0<\/em><\/p><p>Le 30 aou\u0302t 2022, FARA a organise\u0301 un webinaire pour mieux comprendre les nouvelles donne\u0301es que Reata Pharmaceuticals a rendues publiques concernant l&#8217;e\u0301tude d&#8217;extension en ouvert (OLE, en cours) sur l\u2019Omaveloxolone. En effet, ces nouvelles donne\u0301es ont un impact sur le calendrier de re\u0301vision de la demande de nouveau me\u0301dicament, NDA, (new drug application) sollicite\u0301e par Reata.\u00a0<\/p><p>Le processus de soumission, d&#8217;examen et d&#8217;approbation du nouveau me\u0301dicament (NDA) se de\u0301roule uniquement entre Reata et la FDA (Food and drug administration). La soumission de nouvelles donne\u0301es a e\u0301te\u0301 conside\u0301re\u0301e comme un amendement a\u0300 la demande initiale ; le report de la date de de\u0301cision d&#8217;une approbation (ou non) (PDUFA) du nouveau me\u0301dicament au 28 fe\u0301vrier 2023, rele\u0300ve uniquement de la FDA.<\/p><p><span style=\"text-decoration: underline;\"><strong>Objectifs et re\u0301sultats des e\u0301tudes sur l\u2019Omaveloxolone mene\u0301es par Reata (MOXIe)<\/strong><\/span><br \/>Deux e\u0301tudes ont e\u0301te\u0301 pre\u0301alablement re\u0301alise\u0301es par Reata. L\u2019une pour identifier la dose optimale a\u0300 utiliser, la seconde pour e\u0301valuer la se\u0301curite\u0301 et l\u2019efficacite\u0301 de 150 mg de l\u2019Omaveloxolone (Omav).<\/p><p><span style=\"text-decoration: underline;\"><strong>Re\u0301sultats<\/strong><\/span><\/p><p>Il ressort de l&#8217;e\u0301valuation par la mFARS dans les activite\u0301s quotidiennes et par d\u2019autres mesures d\u2019efficacite\u0301, qu&#8217;Omav ame\u0301liore significativement la fonction neurologique. Il a e\u0301te\u0301 en ge\u0301ne\u0301ral bien tole\u0301re\u0301 par les patients AF.<\/p><p><strong>Le compte rendu complet est disponible sur la page &#8220;<a href=\"https:\/\/www.afaf.asso.fr\/la-recherche\/etudes-et-essais-cliniques#principaux-essais-etudes-cliniques-en-cours\">Etudes &amp; essais cliniques<\/a>&#8220;, vous pouvez aussi y acc\u00e9der <a href=\"https:\/\/www.afaf.asso.fr\/wp-content\/uploads\/2023\/01\/2022-09-essai-omav-REATA.pdf\" target=\"_blank\" rel=\"noopener\">directement par ce lien<\/a>.<br \/><\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Cet article explique la m\u00e9thodologie de l\u2019\u00e9tude sur l&#8217;Omaveloxolone men\u00e9e par Reata (MOXIe), les r\u00e9sultats, le processus de soumission, le calendrier etc. Compte-rendu de Cecilia Estrella sur la base du webinaire\u00a0de FARA avec Jen Farmer, David Lynch et Layne Rodden.\u00a0 Le 30 aou\u0302t 2022, FARA a organise\u0301 un webinaire pour mieux comprendre les nouvelles donne\u0301es [&hellip;]<\/p>\n","protected":false},"author":9,"featured_media":7805,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"ocean_front_end_style_editor":"no","ocean_post_layout":"","ocean_both_sidebars_style":"","ocean_both_sidebars_content_width":0,"ocean_both_sidebars_sidebars_width":0,"ocean_sidebar":"0","ocean_second_sidebar":"0","ocean_disable_margins":"enable","ocean_add_body_class":"","ocean_shortcode_before_top_bar":"","ocean_shortcode_after_top_bar":"","ocean_shortcode_before_header":"","ocean_shortcode_after_header":"","ocean_has_shortcode":"","ocean_shortcode_after_title":"","ocean_shortcode_before_footer_widgets":"","ocean_shortcode_after_footer_widgets":"","ocean_shortcode_before_footer_bottom":"","ocean_shortcode_after_footer_bottom":"","ocean_display_top_bar":"default","ocean_display_header":"default","ocean_header_style":"","ocean_center_header_left_menu":"0","ocean_custom_header_template":"0","ocean_custom_logo":0,"ocean_custom_retina_logo":0,"ocean_custom_logo_max_width":0,"ocean_custom_logo_tablet_max_width":0,"ocean_custom_logo_mobile_max_width":0,"ocean_custom_logo_max_height":0,"ocean_custom_logo_tablet_max_height":0,"ocean_custom_logo_mobile_max_height":0,"ocean_header_custom_menu":"0","ocean_menu_typo_font_family":"0","ocean_menu_typo_font_subset":"","ocean_menu_typo_font_size":0,"ocean_menu_typo_font_size_tablet":0,"ocean_menu_typo_font_size_mobile":0,"ocean_menu_typo_font_size_unit":"px","ocean_menu_typo_font_weight":"","ocean_menu_typo_font_weight_tablet":"","ocean_menu_typo_font_weight_mobile":"","ocean_menu_typo_transform":"","ocean_menu_typo_transform_tablet":"","ocean_menu_typo_transform_mobile":"","ocean_menu_typo_line_height":0,"ocean_menu_typo_line_height_tablet":0,"ocean_menu_typo_line_height_mobile":0,"ocean_menu_typo_line_height_unit":"","ocean_menu_typo_spacing":0,"ocean_menu_typo_spacing_tablet":0,"ocean_menu_typo_spacing_mobile":0,"ocean_menu_typo_spacing_unit":"","ocean_menu_link_color":"","ocean_menu_link_color_hover":"","ocean_menu_link_color_active":"","ocean_menu_link_background":"","ocean_menu_link_hover_background":"","ocean_menu_link_active_background":"","ocean_menu_social_links_bg":"","ocean_menu_social_hover_links_bg":"","ocean_menu_social_links_color":"","ocean_menu_social_hover_links_color":"","ocean_disable_title":"default","ocean_disable_heading":"default","ocean_post_title":"","ocean_post_subheading":"","ocean_post_title_style":"","ocean_post_title_background_color":"","ocean_post_title_background":0,"ocean_post_title_bg_image_position":"","ocean_post_title_bg_image_attachment":"","ocean_post_title_bg_image_repeat":"","ocean_post_title_bg_image_size":"","ocean_post_title_height":0,"ocean_post_title_bg_overlay":0.5,"ocean_post_title_bg_overlay_color":"","ocean_disable_breadcrumbs":"default","ocean_breadcrumbs_color":"","ocean_breadcrumbs_separator_color":"","ocean_breadcrumbs_links_color":"","ocean_breadcrumbs_links_hover_color":"","ocean_display_footer_widgets":"default","ocean_display_footer_bottom":"default","ocean_custom_footer_template":"0","ocean_post_oembed":"","ocean_post_self_hosted_media":"","ocean_post_video_embed":"","ocean_link_format":"","ocean_link_format_target":"self","ocean_quote_format":"","ocean_quote_format_link":"post","ocean_gallery_link_images":"off","ocean_gallery_id":[],"footnotes":""},"categories":[43],"tags":[],"class_list":["post-5615","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-informations_recherche","entry","has-media","owp-thumbs-layout-horizontal","owp-btn-normal","owp-tabs-layout-section","has-no-thumbnails"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.1 - 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