{"id":263,"date":"2025-08-28T16:39:18","date_gmt":"2025-08-28T09:39:18","guid":{"rendered":"https:\/\/pythonsonline.com\/index.php\/2025\/08\/28\/perawatan-pah-cereno-scientific-mendapat-status-jalur-cepat-fda\/"},"modified":"2025-08-28T16:39:18","modified_gmt":"2025-08-28T09:39:18","slug":"perawatan-pah-cereno-scientific-mendapat-status-jalur-cepat-fda","status":"publish","type":"post","link":"https:\/\/pythonsonline.com\/index.php\/2025\/08\/28\/perawatan-pah-cereno-scientific-mendapat-status-jalur-cepat-fda\/","title":{"rendered":"Perawatan PAH Cereno Scientific Mendapat Status Jalur Cepat FDA"},"content":{"rendered":"<div>\n<div class=\"\">\n<div style=\"width:30%;float:left;max-width:525px;margin:0 1.5rem 1.5rem 0;clear:both;cursor:\" class=\" figure\">\n<div id=\"image-caption\" class=\"text-gray-500 italic\">\n<div class=\"blockText_blockContent__TbCXh\">\n<p class=\"pb-2\">Paru -paru dengan tuberkulosis, penyakit covid panjang atau asma, sel kanker, virus dan polusi udara, tanpa hari tembakau, donasi organ | Kredit Gambar: \u00a9 Berit Kessler &#8211; Stock.adobe.com<\/p>\n<\/div>\n<\/div>\n<div class=\"hidden top-(-100%) block w-(1px) transition-opacity duration-500 ease-in-out opacity-0 overflow-hidden\"><img decoding=\"async\" class=\"m-auto absolute inset-0 max-w-(0%) max-h-(0%) border-(3px) border-solid border-white shadow-(0px_0px_8px_rgba(0,0,0,0.3)) box-border transition ease-in-out duration-500\" src=\"https:\/\/cdn.sanity.io\/images\/0vv8moc6\/pharmtech\/612a4481dcdc3ca265a43cf215ea5a2fc10e1342-6076x4051.jpg?fit=crop&amp;auto=format\"\/><\/div>\n<\/div>\n<\/div>\n<p class=\"pb-2\">FDA telah memberikan penunjukan jalur cepat untuk Cereno Scientific (CERENO) yang berbasis di Swedia untuk program utama perusahaan, CS1, pengobatan untuk hipertensi arteri paru (PAH) (1). Cereno mengumumkan keputusan FDA dalam siaran pers pada 26 Agustus 2025.<\/p>\n<h2 class=\"text-2xl pb-4 pt-2\"><strong>Mendorong hasil percobaan<\/strong><\/h2>\n<p class=\"pb-2\">PAH adalah penyakit progresif yang jarang terjadi-ditandai oleh pasien yang memiliki tekanan darah tinggi yang tidak normal di arteri di paru-paru-di mana terapi yang lebih aman dan pemodifikasi penyakit sangat membutuhkan, menurut Cereno (1,2). CS1 berfungsi sebagai inhibitor histone deacetylase oral yang menurut Cereno memiliki mekanisme aksi yang unik melalui modulasi epigenetik.<\/p>\n<p class=\"pb-2\">Cereno melaporkan bahwa CS1 menunjukkan kemanjuran yang menggembirakan sambil memenuhi titik akhir keamanan dan tolerabilitas utamanya dalam uji coba fase IIA pada pasien dengan PAH, termasuk peningkatan berikut: mengungkapkan skor risiko, kelas fungsional, dan kualitas hidup, ditambah tanda -tanda awal dari kedua renovasi vaskular terbalik dan fungsi jantung kanan (1).<\/p>\n<p class=\"pb-2\">Uji coba fase IIB saat ini sedang dipersiapkan.<\/p>\n<h2 class=\"text-2xl pb-4 pt-2\"><strong>Seberapa cepat trek dapat membantu<\/strong><\/h2>\n<p class=\"pb-2\">&#8220;Penunjukan jalur cepat untuk CS1 menggarisbawahi pengakuan FDA tentang potensinya untuk memenuhi kebutuhan yang tidak terpenuhi yang signifikan dalam PAH,&#8221; kata Rahul Agrawal, MD, kepala petugas medis dan kepala R&#038;D di Cereno Scientific, dalam siaran pers (1). \u201cPenunjukan jalur cepat akan memungkinkan interaksi yang lebih dekat dengan FDA, memungkinkan umpan balik tepat waktu pada rencana pengembangan kami saat kami memajukan CS1 ke dalam uji coba fase IIB dan seterusnya. Penunjukan ini menandai langkah penting dalam perjalanan pengembangan untuk CS1 dan mendukung tujuan kami untuk membuat pilihan perawatan inovatif yang tersedia bagi pasien PAH sebagaimana mungkin.\u201d<\/p>\n<p class=\"pb-2\">CEO Cereno Sten R. S\u00f6rensen setuju, menegaskan bahwa penunjukan membawa Cereno ke dalam interaksi yang lebih dekat dan lebih sering dengan FDA, serta kelayakan untuk peninjauan gulungan dan potensi peninjauan prioritas (1).<\/p>\n<p class=\"pb-2\">\u201cKami sangat senang telah mencapai penunjukan jalur cepat untuk CS1, yang keduanya memvalidasi kekuatan program CS1 kami dan mendukung misi kami untuk membawa perawatan perintis kepada pasien dengan penyakit langka yang menghancurkan seperti PAH,\u201d kata S\u00f6rensen dalam rilis (1). \u201cUntuk pasien, (program) jalur cepat (program) dapat mempercepat jalur menuju terapi baru. Bagi Cereno, itu adalah tonggak penting yang meningkatkan nilai CS1, memperkuat posisi kompetitif kami, dan menciptakan peluang lebih lanjut untuk kolaborasi strategis.\u201d<\/p>\n<h2 class=\"text-2xl pb-4 pt-2\"><strong>Kemajuan lain untuk PAH<\/strong><\/h2>\n<p class=\"pb-2\">Beberapa perawatan untuk PAH maju pada tahun 2024. Pada bulan Juni tahun itu, Badan Obat -obatan Eropa (EMA) memberikan otorisasi pemasaran di Uni Eropa kepada Merck (dikenal sebagai MSD di luar Amerika Serikat dan Kanada) WinRevair (Sotatercept), sebagai sarana untuk meningkatkan kapasitas olahraga pada pasien dengan PAH (2). Perlakuan resmi menerima persetujuan Komisi Eropa (EC) pada Agustus 2024 (3).<\/p>\n<p class=\"pb-2\">Pada bulan September 2024, juga mengikuti pendapat positif dari Komite EMA untuk Produk Obat untuk Penggunaan Manusia (CHMP), EC yang disetujui Yuvanci Johnson &#038; Johnson (Macitentan\/Tadalafil) untuk pengobatan PAH (4).<\/p>\n<h2 class=\"text-2xl pb-4 pt-2\"><strong>Referensi<\/strong><\/h2>\n<p class=\"pb-2\">1. Cereno Scientific. Cereno Scientific memberikan penunjukan jalur cepat FDA untuk CS1 pada penyakit arteri paru -paru langka (PAH). Siaran pers. 26 Agustus 2025.<br \/>2. EMA. Pendapat CHMP positif tentang pengobatan kelas satu untuk mengobati hipertensi arteri paru. Siaran pers. 28 Juni 2024.<br \/>3. Merck. Merck menerima persetujuan Komisi Eropa untuk WinRevair (Sotatercept) dalam kombinasi dengan terapi hipertensi arteri paru (PAH) lainnya, untuk pengobatan PAH pada pasien dewasa dengan Kelas II-III fungsional. Siaran pers. 26 Agustus 2024.<br \/>4. Johnson &#038; Johnson. Komisi Eropa menyetujui Yuvanci (terapi kombinasi tablet tunggal (STCT) dari Macitentan dan Tadalafil) untuk pengobatan pasien dengan hipertensi arteri paru (PAH). Siaran pers. 30 September 2024.<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Paru -paru dengan tuberkulosis, penyakit covid panjang atau asma, sel kanker, virus dan polusi udara, tanpa hari tembakau, donasi organ | Kredit Gambar: \u00a9 Berit Kessler &#8211; Stock.adobe.com FDA telah memberikan penunjukan jalur cepat untuk Cereno Scientific (CERENO) yang berbasis di Swedia untuk program utama perusahaan, CS1, pengobatan untuk hipertensi arteri paru (PAH) (1). Cereno [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":264,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-263","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.9 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Perawatan PAH Cereno Scientific Mendapat Status Jalur Cepat FDA - Nova Anggreni, S.Farm, APT<\/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:\/\/pythonsonline.com\/index.php\/2025\/08\/28\/perawatan-pah-cereno-scientific-mendapat-status-jalur-cepat-fda\/\" \/>\n<meta property=\"og:locale\" content=\"id_ID\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Perawatan PAH Cereno Scientific Mendapat Status Jalur Cepat FDA - Nova Anggreni, S.Farm, APT\" \/>\n<meta property=\"og:description\" content=\"Paru -paru dengan tuberkulosis, penyakit covid panjang atau asma, sel kanker, virus dan polusi udara, tanpa hari tembakau, donasi organ | Kredit Gambar: \u00a9 Berit Kessler &#8211; Stock.adobe.com FDA telah memberikan penunjukan jalur cepat untuk Cereno Scientific (CERENO) yang berbasis di Swedia untuk program utama perusahaan, CS1, pengobatan untuk hipertensi arteri paru (PAH) (1). 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