{"id":3022,"date":"2019-01-23T16:45:49","date_gmt":"2019-01-23T09:45:49","guid":{"rendered":"https:\/\/www.vnras.com\/drug\/?p=3022"},"modified":"2019-01-23T16:45:49","modified_gmt":"2019-01-23T09:45:49","slug":"danh-sach-thuoc-duoc-fda-phe-chuan-trong-nam-2018","status":"publish","type":"post","link":"https:\/\/vnras.com\/drug\/danh-sach-thuoc-duoc-fda-phe-chuan-trong-nam-2018\/","title":{"rendered":"DANH S\u00c1CH THU\u1ed0C \u0110\u01af\u1ee2C FDA PH\u00ca CHU\u1ea8N TRONG N\u0102M 2018"},"content":{"rendered":"<p>N\u0103m 2018 l\u00e0 m\u1ed9t n\u0103m bi\u1ec3u ng\u1eef c\u1ee7a C\u1ee5c Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m Hoa K\u1ef3 (FDA), v\u1edbi 59 lo\u1ea1i thu\u1ed1c m\u1edbi \u0111\u01b0\u1ee3c Trung t\u00e2m \u0110\u00e1nh gi\u00e1 v\u00e0 Nghi\u00ean c\u1ee9u Thu\u1ed1c (CDER) ph\u00ea duy\u1ec7t, bao g\u1ed3m 19 c\u00f4ng ty h\u1ea1ng nh\u1ea5t, 34 lo\u1ea1i thu\u1ed1c m\u1edbi cho c\u00e1c b\u1ec7nh hi\u1ebfm g\u1eb7p v\u00e0 m\u1ed9t k\u1ef7 l\u1ee5c b\u1ea3y sinh h\u1ecdc.<\/p>\n<p>59 ph\u00ea duy\u1ec7t thu\u1ed1c n\u0103m 2018 l\u00e0 nhi\u1ec1u nh\u1ea5t trong h\u01a1n 10 n\u0103m; 46 lo\u1ea1i thu\u1ed1c m\u1edbi \u0111\u00e3 \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t trong n\u0103m 2017 v\u00e0 22 lo\u1ea1i \u0111\u00e3 \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t v\u00e0o n\u0103m 2016. T\u1eeb n\u0103m 2009 \u0111\u1ebfn 2017, CDER trung b\u00ecnh c\u00f3 kho\u1ea3ng 33 lo\u1ea1i thu\u1ed1c m\u1edbi \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t m\u1ed7i n\u0103m.<\/p>\n<p>Trong s\u1ed1 59 lo\u1ea1i thu\u1ed1c m\u1edbi \u0111\u01b0\u1ee3c CDER ph\u00ea duy\u1ec7t, 43 (73%) \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 \u01b0u ti\u00ean, 24 (41%) \u0111\u01b0\u1ee3c theo d\u00f5i nhanh v\u00e0 14 (24%) \u0111\u01b0\u1ee3c ch\u1ec9 \u0111\u1ecbnh l\u00e0 li\u1ec7u ph\u00e1p \u0111\u1ed9t ph\u00e1. Quy\u1ebft \u0111\u1ecbnh v\u1ec1 t\u1ea5t c\u1ea3 59 lo\u1ea1i thu\u1ed1c th\u01b0\u1eddng \u0111\u01b0\u1ee3c ho\u00e0n th\u00e0nh tr\u01b0\u1edbc ho\u1eb7c tr\u01b0\u1edbc ng\u00e0y m\u1ee5c ti\u00eau c\u1ee7a ch\u00fang.<\/p>\n<p>N\u0103m 2018 \u0111\u00e3 ch\u1ee9ng ki\u1ebfn \u200b\u200blo\u1ea1i thu\u1ed1c \u0111\u1ea7u ti\u00ean c\u00f3 ngu\u1ed3n g\u1ed1c t\u1eeb c\u1ea7n sa \u0111\u1ec3 lo\u1ea1i b\u1ecf FDA, v\u1edbi s\u1ef1 ch\u1ea5p thu\u1eadn c\u1ee7a m\u1ed9t c\u00f4ng th\u1ee9c tinh ch\u1ebf cannabidiol ( dung d\u1ecbch u\u1ed1ng Epidiolex , D\u01b0\u1ee3c ph\u1ea9m GW) \u0111\u1ec3 \u0111i\u1ec1u tr\u1ecb c\u00e1c c\u01a1n \u0111\u1ed9ng kinh li\u00ean quan \u0111\u1ebfn hai d\u1ea1ng \u0111\u1ed9ng kinh hi\u1ebfm g\u1eb7p &#8211; h\u1ed9i ch\u1ee9ng Lennox-Gastaut &#8211; cho b\u1ec7nh nh\u00e2n l\u1edbn h\u01a1n 2 tu\u1ed5i.<\/p>\n<p>FDA c\u0169ng \u0111\u00e3 ph\u00ea duy\u1ec7t m\u1ed9t lo\u1ea1i thu\u1ed1c m\u1edbi th\u1ee9 hai cho h\u1ed9i ch\u1ee9ng Dravet &#8211; Stiripentol ( Diacomit , Biocodex). Thu\u1ed1c n\u00e0y v\u00e0 Epidiolex l\u00e0 ph\u01b0\u01a1ng ph\u00e1p \u0111i\u1ec1u tr\u1ecb duy nh\u1ea5t \u0111\u01b0\u1ee3c FDA ch\u1ea5p thu\u1eadn cho b\u1ec7nh nh\u00e2n m\u1eafc h\u1ed9i ch\u1ee9ng Dravet.<\/p>\n<p>C\u00e1c ph\u00ea duy\u1ec7t thu\u1ed1c \u0111\u00e1ng ch\u00fa \u00fd kh\u00e1c \u0111\u1ed1i v\u1edbi c\u00e1c b\u1ec7nh hi\u1ebfm g\u1eb7p ho\u1eb7c m\u1ed3 c\u00f4i \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn 200.000 ho\u1eb7c \u00edt h\u01a1n ng\u01b0\u1eddi M\u1ef9 bao g\u1ed3m:<\/p>\n<ul>\n<li>Migalastat ( Galafold , Amicus Therapeutics) cho b\u1ec7nh Fabry g\u00e2y ra do \u0111\u1ed9t bi\u1ebfn gen c\u00f3 th\u1ec3 \u0111i\u1ec1u tr\u1ecb b\u1eb1ng thu\u1ed1c \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh d\u1ef1a tr\u00ean d\u1eef li\u1ec7u x\u00e9t nghi\u1ec7m in vitro. Migalastat l\u00e0 thu\u1ed1c u\u1ed1ng \u0111\u1ea7u ti\u00ean cho b\u1ec7nh Fabry v\u00e0 l\u00e0 li\u1ec7u ph\u00e1p m\u1edbi \u0111\u1ea7u ti\u00ean \u0111\u01b0\u1ee3c ch\u1ea5p thu\u1eadn \u0111\u1ec3 \u0111i\u1ec1u tr\u1ecb c\u0103n b\u1ec7nh hi\u1ebfm g\u1eb7p n\u00e0y \u1edf Hoa K\u1ef3 trong h\u01a1n 15 n\u0103m.<\/li>\n<li>Burosumab ( Crysvita , Ultragenyx Pharmaceutical Inc), lo\u1ea1i thu\u1ed1c \u0111\u1ea7u ti\u00ean \u0111\u01b0\u1ee3c ch\u1ea5p thu\u1eadn \u0111\u1ec3 \u0111i\u1ec1u tr\u1ecb cho ng\u01b0\u1eddi l\u1edbn v\u00e0 tr\u1ebb em t\u1eeb 1 tu\u1ed5i tr\u1edf l\u00ean v\u1edbi ch\u1ee9ng gi\u1ea3m phosphat li\u00ean k\u1ebft X, m\u1ed9t d\u1ea1ng b\u1ec7nh c\u00f2i x\u01b0\u01a1ng hi\u1ebfm g\u1eb7p, di truy\u1ec1n.<\/li>\n<li>Pegvaliase ( Palynziq, BioMarin Pharmaceutical Inc), d\u00e0nh cho ng\u01b0\u1eddi l\u1edbn m\u1eafc b\u1ec7nh di truy\u1ec1n hi\u1ebfm g\u1eb7p phenylketon ni\u1ec7u (PKU). Palynziq l\u00e0 li\u1ec7u ph\u00e1p thay th\u1ebf enzyme \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t \u0111\u1ea7u ti\u00ean nh\u1eafm v\u00e0o nguy\u00ean nh\u00e2n c\u01a1 b\u1ea3n c\u1ee7a PKU.<\/li>\n<li>Amifampridine ( Firdapse , Catalyst D\u01b0\u1ee3c ph\u1ea9m), thu\u1ed1c ch\u1eb9n k\u00eanh kali v\u00e0 \u0111i\u1ec1u tr\u1ecb \u0111\u1ea7u ti\u00ean \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t c\u1ee7a h\u1ed9i ch\u1ee9ng nh\u01b0\u1ee3c c\u01a1 Lambert-Eaton \u1edf ng\u01b0\u1eddi l\u1edbn.<\/li>\n<li>Cearermin ( Oxervate , Domp\u00e9 Farmaceutici SpA) trong \u0111i\u1ec1u tr\u1ecb vi\u00eam gi\u00e1c m\u1ea1c th\u1ea7n kinh , m\u1ed9t b\u1ec7nh hi\u1ebfm g\u1eb7p v\u00e0 nghi\u00eam tr\u1ecdng \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn gi\u00e1c m\u1ea1c c\u1ee7a m\u1eaft.<\/li>\n<li>Elapegademase ( Revcovi , Khoa h\u1ecdc sinh h\u1ecdc ch\u00ec) cho ng\u01b0\u1eddi l\u1edbn v\u00e0 tr\u1ebb em b\u1ecb suy gi\u1ea3m mi\u1ec5n d\u1ecbch k\u1ebft h\u1ee3p nghi\u00eam tr\u1ecdng adenosine deaminase (ADA-SCID), m\u1ed9t r\u1ed1i lo\u1ea1n chuy\u1ec3n h\u00f3a hi\u1ebfm g\u1eb7p g\u00e2y suy gi\u1ea3m mi\u1ec5n d\u1ecbch nghi\u00eam tr\u1ecdng v\u00e0 \u0111e d\u1ecda t\u00ednh m\u1ea1ng m\u00e0 kh\u00f4ng \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb.<\/li>\n<li>C\u00e1c t\u00e1c nh\u00e2n h\u1ea1ng nh\u1ea5t \u0111\u00e1ng ch\u00fa \u00fd bao g\u1ed3m lofexidine hydrochloride ( Lucemyra , US WorldMeds), lo\u1ea1i thu\u1ed1c nonopioid \u0111\u1ea7u ti\u00ean \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t \u0111\u1ec3 gi\u00fap gi\u1ea3m c\u00e1c tri\u1ec7u ch\u1ee9ng cai nghi\u1ec7n opioid v\u00e0 t\u1ea1o \u0111i\u1ec1u ki\u1ec7n ng\u01b0ng s\u1eed d\u1ee5ng opioid \u0111\u1ed9t ng\u1ed9t \u1edf ng\u01b0\u1eddi l\u1edbn.<\/li>\n<\/ul>\n<p>Ngu\u1ed3n:\u00a0<a href=\"https:\/\/www.medscape.com\/viewarticle\/907364?fbclid=IwAR3ScMJ9Rmh3KcfIx8ztKC4m7voOQUfq4TTNOJzarvKvL7k5LltAPRYwDSQ\" rel=\"noopener\">https:\/\/www.medscape.com\/viewarticle\/907364?fbclid=IwAR3ScMJ9Rmh3KcfIx8ztKC4m7voOQUfq4TTNOJzarvKvL7k5LltAPRYwDSQ<\/a><\/p>\n<p>\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>\u00a0<\/p>\n","protected":false},"excerpt":{"rendered":"<p>N\u0103m 2018 l\u00e0 m\u1ed9t n\u0103m bi\u1ec3u ng\u1eef c\u1ee7a C\u1ee5c Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m Hoa K\u1ef3 (FDA), v\u1edbi 59 lo\u1ea1i thu\u1ed1c m\u1edbi \u0111\u01b0\u1ee3c Trung t\u00e2m \u0110\u00e1nh gi\u00e1 v\u00e0 Nghi\u00ean c\u1ee9u Thu\u1ed1c (CDER) ph\u00ea duy\u1ec7t, bao g\u1ed3m 19 c\u00f4ng ty h\u1ea1ng nh\u1ea5t, 34 lo\u1ea1i thu\u1ed1c m\u1edbi cho c\u00e1c b\u1ec7nh hi\u1ebfm g\u1eb7p v\u00e0 m\u1ed9t k\u1ef7 [&#8230;]\n","protected":false},"author":1,"featured_media":3023,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-3022","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-y-te-suc-khoe"],"acf":[],"_links":{"self":[{"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/posts\/3022","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/comments?post=3022"}],"version-history":[{"count":0,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/posts\/3022\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/media\/3023"}],"wp:attachment":[{"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/media?parent=3022"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/categories?post=3022"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/tags?post=3022"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}