{"id":261,"date":"2025-08-27T16:32:00","date_gmt":"2025-08-27T09:32:00","guid":{"rendered":"https:\/\/pythonsonline.com\/index.php\/2025\/08\/27\/gilead-sciences-hiv-prep-suntikan-disetujui-oleh-komisi-eropa\/"},"modified":"2025-08-27T16:32:00","modified_gmt":"2025-08-27T09:32:00","slug":"gilead-sciences-hiv-prep-suntikan-disetujui-oleh-komisi-eropa","status":"publish","type":"post","link":"https:\/\/pythonsonline.com\/index.php\/2025\/08\/27\/gilead-sciences-hiv-prep-suntikan-disetujui-oleh-komisi-eropa\/","title":{"rendered":"Gilead Sciences &#39;HIV Prep Suntikan Disetujui oleh Komisi Eropa"},"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\">19 Februari 2020 Foster City \/ CA \/ USA &#8211; Tanda Gilead di markas mereka di Silicon Valley; Gilead Sciences, Inc. adalah perusahaan bioteknologi Amerika yang meneliti, mengembangkan dan mengkomersialkan obat -obatan | Kredit Gambar: \u00a9 Sundry Photography &#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\/1b5745d08ac3312f19abe4591e0f65ad0b91e102-3760x2508.jpg?fit=crop&amp;auto=format\"\/><\/div>\n<\/div>\n<\/div>\n<p class=\"pb-2\">Komisi Eropa (EC) telah memberikan otorisasi pemasaran untuk Lenacapavir, yang dipasarkan oleh Gilead Sciences (Gilead) sebagai Yeytuo, sebagai dua kali setahun, suntikan human immunodeficiency virus-1 (HIV-1) capsid inhibitor untuk pra-paparan pra-paparan (Prep) terhadap risiko HIV-1 secara seksual). Dalam siaran pers pada 26 Agustus 2025, Gilead mengatakan injeksi Lenacapavir adalah opsi pertama dan satu-satunya yang disetujui, dua kali setahun untuk PrEP di 27 negara anggota Uni Eropa (UE), ditambah Norwegia, Islandia, dan Liechtenstein.<\/p>\n<h2 class=\"text-2xl pb-4 pt-2\"><strong>Persetujuan Terbaru untuk Lenacapavir<\/strong><\/h2>\n<p class=\"pb-2\">Penggunaan Lenacapavir telah disetujui oleh EC pada orang dewasa dan remaja dengan peningkatan risiko akuisisi HIV-1 yang memiliki berat setidaknya 35 kg (77 lbs.) (1). Aplikasi otorisasi pemasaran Gilead ditinjau di bawah garis waktu yang dipercepat oleh Komite Obat -obatan Eropa untuk Produk Obat untuk Penggunaan Manusia, yang mengadopsi pendapat positif tentang perawatan pada Juli 2025.<\/p>\n<p class=\"pb-2\">&#8220;Otorisasi cepat Yeytuo oleh Komisi Eropa menggarisbawahi kekakuan data klinis kami dan potensi transformatif Yeytuo untuk membantu mengatasi kebutuhan yang tidak terpenuhi dalam pencegahan HIV di seluruh Eropa,&#8221; kata Dietmar Berger, MD, PhD, Kepala Petugas Medis di Gilead Sciences, dalam siaran pers (1). \u201cTonggak sejarah ini merupakan bukti dari 17 tahun penelitian Gilead yang memberikan obat persiapan terobosan ini, didukung oleh kepemimpinan selama beberapa dekade dalam inovasi HIV.\u201d<\/p>\n<p class=\"pb-2\">Lenacapavir akan diberikan satu tahun tambahan perlindungan pasar di UE karena indikasi baru, dan otorisasi EC mengikuti FDA, pada Juni 2025, dan pedoman Organisasi Kesehatan Dunia yang merekomendasikan Lenacapavir dua kali setahun sebagai opsi persiapan tambahan untuk tujuan pencegahan HIV (1).<\/p>\n<p class=\"pb-2\">&#8220;Dengan sekitar 25.000 diagnosis HIV baru di UE dan area ekonomi Eropa setiap tahun, jelas bahwa opsi pencegahan saat ini tidak berfungsi untuk semua orang yang membutuhkan atau menginginkannya, terutama di kalangan populasi yang rentan,&#8221; kata Jean-Michel Molina, MD, Universit\u00e9 Paris Cit\u00e9, Profesor Penyakit Menular dan Kepala Departemen Diseas Infectious Infectious di Saint-Laribo di Departemen Suci, dan Kepala Departemen Menular Infectious di Departemen Diseas Infectious di The Saint-Laribo di Departemen Suci di Departemen Diseas Infectious Infectious di departemen infeksius di The Saint-Laribo di (1). &#8220;Jadwal dosis novel Yeytuo dua kali setahun dan kemanjuran tinggi bisa menjadi opsi pencegahan HIV transformatif di Eropa yang telah kami tunggu-tunggu untuk membantu kami mengurangi infeksi baru dan membuat kemajuan nyata menuju mengakhiri epidemi HIV.&#8221;<\/p>\n<h2 class=\"text-2xl pb-4 pt-2\"><strong>Perjalanan Gilead pada tahun 2025 sejauh ini<\/strong><\/h2>\n<p class=\"pb-2\">Kemajuan lain yang diperoleh oleh Gilead sebelumnya pada tahun 2025 adalah pemberian EC atas otorisasi pemasaran bersyarat untuk seladelpar perusahaan, oral, peroxisome proliferator yang diaktifkan-Delta agonis, untuk pengobatan ubi-poundsed ubi-uDADECE, baik yang mengalami incponse, baik dalam kombinasi dengan kombinasi dengan kombinasi Ursodeox Acid (puvexecce, baik dalam kombinasi dengan kombinasi Ursodeox Acid (puvexecing, baik dalam kombinasi Ursodeox Acid (puvexe) Monoterapi pada pasien tidak dapat mentolerir UDCA (2).<\/p>\n<p class=\"pb-2\">Namun, Gilead juga memangkas hampir 150 pekerjaan di Foster City, California, markas, bagian dari gelombang PHK di industri bio\/farmasi pada paruh pertama 2025-yang dilaporkan 32% tahun-ke-tahun peningkatan dalam periode waktu itu (3).<\/p>\n<p class=\"pb-2\">Pada tanggal 31 Juli 2025, Gilead termasuk di antara 17 perusahaan di industri untuk menerima surat dari Presiden AS Donald Trump yang menguraikan langkah-langkah yang masing-masing harus diambil untuk menurunkan harga obat resep di Amerika Serikat dengan harga terendah yang ditawarkan di antara negara-negara maju lainnya, yang dikenal sebagai strategi negara yang paling disukai (4).<\/p>\n<p class=\"pb-2\">Perusahaan akan menjadi salah satu organisasi yang berpartisipasi di peluang kemitraan dalam konferensi pemberian obat, yang dijadwalkan 27\u201328 Oktober 2025 di Boston (5).<\/p>\n<h2 class=\"text-2xl pb-4 pt-2\"><strong>Referensi<\/strong><\/h2>\n<p class=\"pb-2\">1. Ilmu Gilead. Komisi Eropa mengesahkan Yeytuo (Lenacapavir) dua kali setahun untuk pencegahan HIV. Siaran pers. 26 Agustus 2025.<br \/>2. Ilmu Gilead. Seladelpar Gilead memberikan otorisasi pemasaran Eropa bersyarat untuk pengobatan kolangitis bilier primer. Siaran pers. 20 Februari 2025.<br \/>3. Cole, C. PHK Sarepta apa, dan lainnya di seluruh Biopharma, berarti bagi para profesional industri. <em>Biopharminternational.com<\/em>17 Juli 2025.<br \/>4. Gedung Putih. Lembar Fakta: Presiden Donald J. Trump mengumumkan tindakan untuk membuat orang Amerika mendapatkan harga terbaik di dunia untuk obat resep. <em>Whitehouse.gov<\/em>31 Juli 2025.<br \/>5. Cole, C. Podd 2025 Mengungkap Agenda Menyoroti Inovasi dalam Teknologi Pemberian Obat. <em>Pharmtech.com<\/em>16 Juli 2025.<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>19 Februari 2020 Foster City \/ CA \/ USA &#8211; Tanda Gilead di markas mereka di Silicon Valley; Gilead Sciences, Inc. adalah perusahaan bioteknologi Amerika yang meneliti, mengembangkan dan mengkomersialkan obat -obatan | Kredit Gambar: \u00a9 Sundry Photography &#8211; Stock.adobe.com Komisi Eropa (EC) telah memberikan otorisasi pemasaran untuk Lenacapavir, yang dipasarkan oleh Gilead Sciences (Gilead) [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":262,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-261","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 - 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