{"id":11488,"date":"2020-11-20T18:02:39","date_gmt":"2020-11-20T23:02:39","guid":{"rendered":"https:\/\/www.progeriaresearch.org\/?p=11488"},"modified":"2022-11-14T17:17:52","modified_gmt":"2022-11-14T22:17:52","slug":"fda-approval","status":"publish","type":"post","link":"https:\/\/www.progeriaresearch.org\/it\/2020\/11\/20\/fda-approval\/","title":{"rendered":"Il giorno \u00e8 arrivato: approvazione della FDA per il primo trattamento contro la Progeria!"},"content":{"rendered":"<p>[et_pb_section fb_built=\u201d1\u2033 _builder_version=\u201d4.16\u2033 global_colors_info=\u201d{}\u201d][et_pb_row _builder_version=\u201d4.16\u2033 background_size=\u201dinitial\u201d background_position=\u201dtop_left\u201d background_repeat=\u201drepeat\u201d global_colors_info=\u201d{}\u201d][et_pb_column type=\u201d4_4\u2033 _builder_version=\u201d4.16\u2033 custom_padding=\u201d|||\u201d global_colors_info=\u201d{}\u201d custom_padding__hover=\u201d|||\u201d][et_pb_text admin_label=\u201dFDA\u201d _builder_version=\u201d4.18.1\u2033 background_size=\u201dinitial\u201d background_position=\u201dtop_left\u201d background_repeat=\u201drepeat\u201d hover_enabled=\u201d0\u2033 global_colors_info=\u201d{}\u201d sticky_enabled=\u201d0\u2033]<\/p>\n<p style=\"font-weight: 400;\"><strong><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-11496 size-medium alignleft\" src=\"https:\/\/www.progeriaresearch.org\/wp-content\/uploads\/2020\/11\/FDA-page-169x300.jpg\" alt=\"\" width=\"169\" height=\"300\" srcset=\"https:\/\/www.progeriaresearch.org\/wp-content\/uploads\/2020\/11\/FDA-page-169x300.jpg 169w, https:\/\/www.progeriaresearch.org\/wp-content\/uploads\/2020\/11\/FDA-page.jpg 300w\" sizes=\"(max-width: 169px) 100vw, 169px\" \/><\/strong>Ultime, entusiasmanti notizie! Il 20 novembre 2020, PRF ha raggiunto un pezzo importante della nostra missione: <strong>lonafarnib, il primo trattamento in assoluto per la progeria, ha ottenuto l&#039;approvazione della FDA<\/strong>.<\/p>\n<p>La progeria ora si unisce a meno di\u00a0<strong>5% delle malattie rare con un trattamento approvato dalla FDA.*\u00a0<\/strong>Negli Stati Uniti, i bambini e i giovani adulti affetti da Progeria possono ora accedere al lonafarnib tramite prescrizione medica, anzich\u00e9 tramite una sperimentazione clinica.<\/p>\n<p>Questa pietra miliare \u00e8 arrivata grazie a 13 anni di ricerca costante che ha coinvolto <a href=\"https:\/\/www.progeriaresearch.org\/it\/clinical-trials\/\">quattro sperimentazioni cliniche<\/a>, il tutto coordinato da PRF, reso possibile dai coraggiosi bambini e dalle loro famiglie e finanziato da voi, la meravigliosa comunit\u00e0 di donatori di PRF.<\/p>\n<p>Siamo inoltre grati ai team di ricerca sulla Progeria di fama mondiale del Boston Children&#039;s Hospital, dell&#039;Hasbro Children&#039;s Hospital, del Brigham and Women&#039;s Hospital, della Brown University, della Boston University e dei National Institutes of Health. Anche i partner farmaceutici che hanno fornito gratuitamente lonafarnib alle sperimentazioni cliniche supportate da PRF sono stati fondamentali, tra cui Shering-Plough, Merck ** (nota come MSD al di fuori degli Stati Uniti e del Canada) ed Eiger BioPharmaceuticals, per il loro contributo nel far progredire la ricerca sulla Progeria verso queste straordinarie nuove vette.<\/p>\n<p>I nostri partner presso Eiger si impegnano a fornire un accesso continuo al lonafarnib per i pazienti con Progeria e laminopatie progeroidi con deficit di elaborazione in tutto il mondo e hanno istituito servizi per supportare l&#039;accesso al lonafarnib tramite <em>Eiger OneCare, <\/em>nonch\u00e9 tramite il programma Managed Access Program di Eiger per i pazienti al di fuori degli Stati Uniti. La revisione del lonafarnib da parte dell&#039;Agenzia europea per i medicinali (EMA) \u00e8 ancora in corso e una decisione sull&#039;approvazione da parte dell&#039;EMA \u00e8 prevista per la seconda met\u00e0 del 2021.<\/p>\n<p>GRAZIE A TUTTI per aver supportato la ricerca che ci ha portato a questo punto cruciale. Il vostro continuo supporto ci consente anche di continuare a premere in avanti verso una cura per questi bambini straordinari.<\/p>\n<p><strong>Che modo davvero straordinario per iniziare le festivit\u00e0 e concludere questa stagione incredibilmente<\/strong><strong> stimolante<\/strong> <strong>anno.<\/strong><\/p>\n<p><a href=\"https:\/\/www.progeriaresearch.org\/wp-content\/uploads\/2020\/11\/PRF-Press-Release-Zokinvy-FDA-Approval-FINAL.pdf\" rel=\"attachment wp-att-11508\">Clicca qui per il nostro comunicato stampa<\/a> che fornisce maggiori dettagli su questa notizia storica.<\/p>\n<p>*300 malattie rare per le quali esiste un trattamento approvato dalla FDA (<a href=\"https:\/\/www.rarediseases.info.nih.gov\/diseases\/FDS-orphan-drugs)\/7,000\" data-saferedirecturl=\"https:\/\/www.google.com\/url?q=https:\/\/www.rarediseases.info.nih.gov\/diseases\/FDS-orphan-drugs)\/7,000&amp;source=gmail&amp;ust=1617209033114000&amp;usg=AFQjCNGl8GC3JC7PBWSWbj-cHfQgWmhudQ\">https:\/\/www.rarediseases.info.nih.gov\/diseases\/FDS-orphan-drugs)\/7,000<\/a>\u00a0malattie rare di cui \u00e8 nota la base molecolare (<a href=\"http:\/\/www.omim.org\/\" data-saferedirecturl=\"https:\/\/www.google.com\/url?q=http:\/\/www.OMIM.org&amp;source=gmail&amp;ust=1617209033114000&amp;usg=AFQjCNG6pGE6IFhDHqW6SGpJ5A14AfU7ZA\">www.omim.org<\/a>) =4.2%<\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=\u201d4.16\u2033 background_size=\u201dinitial\u201d background_position=\u201dtop_left\u201d background_repeat=\u201drepeat\u201d global_colors_info=\u201d{}\u201d][et_pb_column type=\u201d4_4\u2033 _builder_version=\u201d4.16\u2033 custom_padding=\u201d|||\u201d global_colors_info=\u201d{}\u201d custom_padding__hover=\u201d|||\u201d][et_pb_text admin_label=\u201dFDA\u201d _builder_version=\u201d4.16\u2033 text_font_size=\u201d13px\u201d background_size=\u201dinitial\u201d background_position=\u201dtop_left\u201d background_repeat=\u201drepeat\u201d global_colors_info=\u201d{}\u201d]<\/p>\n<p><span>**\u00a0<\/span><span>PRF desidera riconoscere i contributi critici degli scienziati di Schering-Plough \/ Merck R&amp;D che hanno supportato<span class=\"m_-8175828865577728923apple-converted-space\">\u00a0<\/span>sia la valutazione del lonafarnib nei modelli preclinici di HGPS sia gli studi clinici nei pazienti con progeria.<span class=\"m_-8175828865577728923apple-converted-space\">\u00a0<\/span>team, guidato da W. Robert Bishop, John Piwinski, Cecil Pickett e Catherine Strader, ha supportato gli studi farmacocinetici\/farmacodinamici, ha ottimizzato la formulazione dei farmaci e ha assicurato un&#039;adeguata fornitura di farmaci durante questi studi. I membri di questo team includevano: Susan Arbuck,<span class=\"m_-8175828865577728923apple-converted-space\">\u00a0<\/span><\/span><span>Arte Bertelsen, Alan Cooper, Emily Frank, David Harris, Georgianna Harris,<span class=\"m_-8175828865577728923apple-converted-space\">\u00a0<\/span>Paul Kirschmeier, Ming Liu, Jin-Keon Pai, Robert Patton, Paul Statkevich, Greg Szpunar, Bohdan Yaremko, Paul Zavodny e Yali Zhu.<\/span><\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>","protected":false},"excerpt":{"rendered":"<p>Siamo entusiasti di annunciare che oggi abbiamo raggiunto un obiettivo importante della missione di PRF: il lonafarnib, il primo trattamento in assoluto per la Progeria, ha ottenuto l&#039;approvazione della FDA. <\/p>","protected":false},"author":2,"featured_media":11491,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":"","_links_to":"","_links_to_target":""},"categories":[2,1],"tags":[],"class_list":["post-11488","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-uncategorized"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>The day has come: FDA approval for first-ever Progeria treatment! - The Progeria Research Foundation<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.progeriaresearch.org\/it\/2020\/11\/20\/fda-approval\/\" \/>\n<meta property=\"og:locale\" content=\"it_IT\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"The day has come: FDA approval for first-ever Progeria treatment! - The Progeria Research Foundation\" \/>\n<meta property=\"og:description\" content=\"We\u2019re thrilled to announce that today, we achieved an important piece of PRF\u2019s mission: lonafarnib, the first-ever treatment for Progeria, has been granted FDA approval.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.progeriaresearch.org\/it\/2020\/11\/20\/fda-approval\/\" \/>\n<meta property=\"og:site_name\" content=\"The Progeria Research Foundation\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/ProgeriaResearch\/\" \/>\n<meta property=\"article:published_time\" content=\"2020-11-20T23:02:39+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2022-11-14T22:17:52+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.progeriaresearch.org\/wp-content\/uploads\/2020\/11\/posthpFDA-e1607461962809.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"200\" \/>\n\t<meta property=\"og:image:height\" content=\"199\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Karen Betournay\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@Progeria\" \/>\n<meta name=\"twitter:site\" content=\"@Progeria\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Karen Betournay\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minuti\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.progeriaresearch.org\/id\/2020\/11\/20\/fda-approval\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.progeriaresearch.org\/id\/2020\/11\/20\/fda-approval\/\"},\"author\":{\"name\":\"Karen Betournay\",\"@id\":\"https:\/\/www.progeriaresearch.org\/ta\/#\/schema\/person\/2be6cec85c11aaef7a7602636c5b9946\"},\"headline\":\"The day has come: FDA approval for first-ever Progeria treatment!\",\"datePublished\":\"2020-11-20T23:02:39+00:00\",\"dateModified\":\"2022-11-14T22:17:52+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.progeriaresearch.org\/id\/2020\/11\/20\/fda-approval\/\"},\"wordCount\":593,\"publisher\":{\"@id\":\"https:\/\/www.progeriaresearch.org\/ta\/#organization\"},\"image\":{\"@id\":\"https:\/\/www.progeriaresearch.org\/id\/2020\/11\/20\/fda-approval\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.progeriaresearch.org\/wp-content\/uploads\/2020\/11\/posthpFDA-e1607461962809.jpg\",\"articleSection\":[\"News\",\"Uncategorized\"],\"inLanguage\":\"it-IT\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.progeriaresearch.org\/id\/2020\/11\/20\/fda-approval\/\",\"url\":\"https:\/\/www.progeriaresearch.org\/id\/2020\/11\/20\/fda-approval\/\",\"name\":\"The day has come: FDA approval for first-ever Progeria treatment! 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