{"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\/nl\/2020\/11\/20\/fda-approval\/","title":{"rendered":"Het is zover: FDA-goedkeuring voor de allereerste behandeling tegen 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>Breaking, spannend nieuws! Op 20 november 2020 heeft PRF een belangrijk onderdeel van onze missie bereikt: <strong>lonafarnib, de allereerste behandeling voor Progeria, heeft goedkeuring gekregen van de FDA<\/strong>.<\/p>\n<p>Progeria komt nu voor bij minder dan\u00a0<strong>5% van de zeldzame ziekten met een door de FDA goedgekeurde behandeling.*\u00a0<\/strong>Kinderen en jongvolwassenen met Progeria in de VS kunnen nu lonafarnib op recept krijgen, in plaats van via een klinische proef.<\/p>\n<p>Deze belangrijke mijlpaal is bereikt dankzij 13 jaar aan vastberaden onderzoek met betrekking tot <a href=\"https:\/\/www.progeriaresearch.org\/nl\/clinical-trials\/\">vier klinische proeven<\/a>, allemaal geco\u00f6rdineerd door PRF, mogelijk gemaakt door de moedige kinderen en hun families, en gefinancierd door u, de geweldige gemeenschap van donateurs van PRF.<\/p>\n<p>We zijn ook dankbaar voor de Progeria-onderzoeksteams van wereldklasse in het Boston Children&#039;s Hospital, Hasbro Children&#039;s Hospital, Brigham and Women&#039;s Hospital, Brown University, Boston University en de National Institutes of Health. Farmaceutische partners die gratis lonafarnib leverden aan door PRF ondersteunde klinische onderzoeken waren ook cruciaal, waaronder Shering-Plough, Merck ** (buiten de VS en Canada bekend als MSD) en Eiger BioPharmaceuticals, voor hun rol in het bevorderen van de vooruitgang in Progeria-onderzoek naar deze buitengewone nieuwe hoogten.<\/p>\n<p>Onze partners bij Eiger zetten zich in om pati\u00ebnten met Progeria en verwerkingsdefici\u00ebnte Progeroid Laminopathie\u00ebn wereldwijd continue toegang tot lonafarnib te bieden, en ze hebben diensten opgezet om de toegang tot lonafarnib te ondersteunen via <em>Eiger OneCare, <\/em>en via het Managed Access Program van Eiger voor pati\u00ebnten buiten de VS. Het Europees Geneesmiddelenbureau (EMA) is nog steeds bezig met het beoordelen van lonafarnib. Naar verwachting zal het EMA in de tweede helft van 2021 een besluit nemen over de goedkeuring ervan.<\/p>\n<p>BEDANKT ALLEMAAL voor het ondersteunen van het onderzoek dat ons tot dit keerpunt heeft gebracht. Uw voortdurende steun stelt ons ook in staat om door te blijven gaan met het nastreven van een remedie voor deze buitengewone kinderen.<\/p>\n<p><strong>Wat een werkelijk opmerkelijke manier om de feestdagen te beginnen en deze ongelooflijk mooie dag te be\u00ebindigen.<\/strong><strong> uitdagend<\/strong> <strong>jaar.<\/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\">Klik hier voor ons persbericht<\/a> waarin meer details over dit historische nieuws worden gegeven.<\/p>\n<p>*300 zeldzame ziekten waarvoor een door de FDA goedgekeurde behandeling bestaat (<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>\u00a0zeldzame ziekten waarvan de moleculaire basis bekend is (<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 wil graag de kritische bijdragen van de wetenschappers van Schering-Plough \/ Merck R&amp;D erkennen die<span class=\"m_-8175828865577728923apple-converted-space\">\u00a0<\/span>zowel de evaluatie van lonafarnib in preklinische modellen van HGPS als de klinische studies bij progeriapati\u00ebnten. Dit<span class=\"m_-8175828865577728923apple-converted-space\">\u00a0<\/span>team, geleid door W. Robert Bishop, John Piwinski, Cecil Pickett en Catherine Strader, ondersteunde farmacokinetische\/farmacodynamische studies, optimaliseerde de formulering van geneesmiddelen en verzekerde een adequate levering van geneesmiddelen gedurende deze studies. Leden van dit team waren: Susan Arbuck,<span class=\"m_-8175828865577728923apple-converted-space\">\u00a0<\/span><\/span><span>Art 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 en Yali Zhu.<\/span><\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>","protected":false},"excerpt":{"rendered":"<p>We zijn verheugd te kunnen melden dat we vandaag een belangrijk onderdeel van de missie van PRF hebben voltooid: lonafarnib, de allereerste behandeling voor Progeria, heeft goedkeuring gekregen van de 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! 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