{"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\/id\/2020\/11\/20\/fda-approval\/","title":{"rendered":"Harinya telah tiba: persetujuan FDA untuk pengobatan Progeria yang pertama!"},"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>Berita yang menggembirakan! Pada tanggal 20 November 2020, PRF berhasil mencapai bagian penting dari misi kami: <strong>lonafarnib, pengobatan pertama untuk Progeria, telah mendapat persetujuan FDA<\/strong>.<\/p>\n<p>Progeria kini bergabung dengan kurang dari\u00a0<strong>5% penyakit langka dengan pengobatan yang disetujui FDA.*\u00a0<\/strong>Anak-anak dan dewasa muda penderita Progeria di AS sekarang dapat mengakses lonafarnib melalui resep, bukan melalui uji klinis.<\/p>\n<p>Tonggak penting ini tercapai berkat 13 tahun penelitian yang melibatkan <a href=\"https:\/\/www.progeriaresearch.org\/id\/clinical-trials\/\">empat uji klinis<\/a>, semuanya dikoordinasikan bersama oleh PRF, dimungkinkan oleh anak-anak pemberani dan keluarga mereka dan didanai oleh Anda, komunitas donatur PRF yang luar biasa.<\/p>\n<p>Kami juga berterima kasih kepada tim peneliti Progeria kelas dunia di Rumah Sakit Anak Boston, Rumah Sakit Anak Hasbro, Rumah Sakit Brigham and Women, Universitas Brown, Universitas Boston, dan Institut Kesehatan Nasional. Mitra farmasi yang memasok lonafarnib gratis untuk uji klinis yang didukung PRF juga sangat penting, termasuk Shering-Plough, Merck ** (dikenal sebagai MSD di luar AS dan Kanada) dan Eiger BioPharmaceuticals, atas peran mereka dalam memajukan penelitian Progeria ke tingkat baru yang luar biasa ini.<\/p>\n<p>Mitra kami di Eiger berkomitmen untuk menyediakan akses berkelanjutan ke lonafarnib bagi pasien Progeria dan Laminopathies Progeroid yang kekurangan pemrosesan di seluruh dunia, dan mereka telah membangun layanan untuk mendukung akses ke lonafarnib melalui <em>Eiger OneCare, <\/em>serta melalui Program Akses Terkelola Eiger untuk pasien di luar AS Tinjauan Badan Obat Eropa (EMA) terhadap lonafarnib masih berlangsung, dengan keputusan mengenai persetujuan EMA diharapkan pada paruh kedua tahun 2021.<\/p>\n<p>TERIMA KASIH SEMUA atas dukungan Anda terhadap penelitian yang telah membawa kita ke titik penting ini. Dukungan Anda yang berkelanjutan juga memungkinkan kami untuk terus maju menuju penyembuhan bagi anak-anak yang luar biasa ini.<\/p>\n<p><strong>Sungguh cara yang luar biasa untuk memulai musim liburan dan mengakhirinya dengan luar biasa.<\/strong><strong> menantang<\/strong> <strong>tahun.<\/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 di sini untuk siaran pers kami<\/a> yang memberikan rincian lebih lanjut tentang berita bersejarah ini.<\/p>\n<p>*300 penyakit langka yang memiliki pengobatan yang disetujui 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>\u00a0penyakit langka yang dasar molekularnya diketahui (<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 ingin mengucapkan terima kasih atas kontribusi penting dari para ilmuwan dari Schering-Plough \/ Merck R&amp;D yang mendukung<span class=\"m_-8175828865577728923apple-converted-space\">\u00a0<\/span>baik evaluasi lonafarnib dalam model praklinis HGPS dan studi klinis pada pasien progeria.<span class=\"m_-8175828865577728923apple-converted-space\">\u00a0<\/span>Tim yang dipimpin oleh W. Robert Bishop, John Piwinski, Cecil Pickett, dan Catherine Strader, mendukung studi farmakokinetik\/farmakodinamik, mengoptimalkan formulasi obat, dan memastikan pasokan obat yang memadai selama studi ini. Anggota tim ini meliputi: Susan Arbuck,<span class=\"m_-8175828865577728923apple-converted-space\">\u00a0<\/span><\/span><span>Seni 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, dan Yali Zhu.<\/span><\/p>\n<p>[\/et_pb_teks][\/et_pb_kolom][\/et_pb_baris][\/et_pb_bagian]<\/p>","protected":false},"excerpt":{"rendered":"<p>Kami sangat gembira mengumumkan bahwa hari ini, kami mencapai bagian penting dari misi PRF: lonafarnib, pengobatan pertama untuk Progeria, telah mendapatkan persetujuan 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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