{"id":4185,"date":"2019-03-09T23:57:52","date_gmt":"2019-03-09T16:57:52","guid":{"rendered":"https:\/\/www.vnras.com\/drug\/?p=4185"},"modified":"2019-03-09T23:57:52","modified_gmt":"2019-03-09T16:57:52","slug":"fda-us-tong-hop-cac-thuoc-moi-duoc-cap-phep-15-11-2017","status":"publish","type":"post","link":"https:\/\/vnras.com\/drug\/fda-us-tong-hop-cac-thuoc-moi-duoc-cap-phep-15-11-2017\/","title":{"rendered":"FDA-US: T\u1ed5ng h\u1ee3p c\u00e1c thu\u1ed1c m\u1edbi \u0111\u01b0\u1ee3c c\u1ea5p ph\u00e9p (15\/11\/2017)"},"content":{"rendered":"<h2>Alibify MyCite: vi\u00ean n\u00e9n t\u00edch h\u1ee3p c\u1ea3m bi\u1ebfn nu\u1ed1t khi b\u1ec7nh nh\u00e2n d\u00f9ng thu\u1ed1c<\/h2>\n<p>H\u1ec7 th\u1ed1ng n\u00e0y s\u1ebd g\u1eedi m\u1ed9t tin nh\u1eafn t\u1eeb c\u1ea3m bi\u1ebfn tr\u00ean vi\u00ean thu\u1ed1c \u0111\u1ebfn m\u1ed9t mi\u1ebfng d\u00e1n \u0111eo tr\u00ean ng\u01b0\u1eddi, sau \u0111\u00f3 truy\u1ec1n t\u1edbi \u0111i\u1ec7n tho\u1ea1i th\u00f4ng minh.<\/p>\n<p>Ng\u01b0\u1eddi ta \u01b0\u1edbc t\u00ednh r\u1eb1ng vi\u1ec7c b\u1ec7nh nh\u00e2n kh\u00f4ng tu\u00e2n th\u1ee7 theo ph\u00e1c \u0111\u1ed3 \u0111i\u1ec1u tr\u1ecb y khoa ti\u00eau t\u1ed1n h\u00e0ng tr\u0103m t\u1ec9 dollar m\u1ed7i n\u0103m cho chi ph\u00ed ch\u0103m s\u00f3c y t\u1ebf c\u00f3 th\u1ec3 tr\u00e1nh \u0111\u01b0\u1ee3c \u1edf Hoa K\u00ec. Trong tu\u1ea7n n\u00e0y, FDA \u0111\u00e3 c\u1ea5p ph\u00e9p cho thu\u1ed1c Abilify MyCite (aripiprazole) c\u1ee7a h\u00e3ng Otsuka, m\u1ed9t thu\u1ed1c ch\u1ed1ng lo\u1ea1n th\u1ea7n kh\u00f4ng \u0111i\u1ec3n h\u00ecnh trong \u0111i\u1ec1u tr\u1ecb t\u00e2m th\u1ea7n ph\u00e2n li\u1ec7t, r\u1ed1i lo\u1ea1n c\u1ea3m x\u00fac l\u01b0\u1ee1ng c\u1ef1c c\u1ea5p t\u00ednh lo\u1ea1i I v\u00e0 h\u1ed7 tr\u1ee3 \u0111i\u1ec1u tr\u1ecb tr\u1ea7m c\u1ea3m \u1edf ng\u01b0\u1eddi l\u1edbn. D\u1ea1ng vi\u00ean n\u00e9n c\u1ee7a Abilify gi\u1edd \u0111\u00e2y \u0111\u01b0\u1ee3c t\u00edch h\u1ee3p v\u1edbi c\u1ea3m bi\u1ebfn Proteus nu\u1ed1t \u0111\u01b0\u1ee3c, cho ph\u00e9p b\u1ec7nh nh\u00e2n (n\u1ebfu h\u1ecd \u0111\u01b0\u1ee3c c\u1ea5p quy\u1ec1n truy c\u1eadp), b\u00e1c s\u0129 v\u00e0 ng\u01b0\u1eddi ch\u0103m s\u00f3c nh\u1eadn bi\u1ebft \u0111\u01b0\u1ee3c vi\u1ec7c b\u1ec7nh nh\u00e2n nu\u1ed1t thu\u1ed1c tr\u00ean m\u00e1y \u0111i\u1ec7n tho\u1ea1i th\u00f4ng minh ho\u1eb7c c\u1ed5ng th\u00f4ng tin web c\u1ee7a h\u1ecd. Tuy nhi\u00ean v\u1eabn ch\u01b0a c\u00f3 h\u1ed3 s\u01a1 ghi l\u1ea1i s\u1ef1 c\u1ea3i thi\u1ec7n vi\u1ec7c tu\u00e2n th\u1ee7 \u0111i\u1ec1u tr\u1ecb c\u1ee7a b\u1ec7nh nh\u00e2n khi d\u00f9ng Abilify. Gi\u00e1 c\u1ee7a thu\u1ed1c n\u00e0y c\u0169ng ch\u01b0a \u0111\u01b0\u1ee3c b\u00e1o c\u00e1o.<\/p>\n<h2>Fasenra v\u1edbi li\u1ec1u d\u00f9ng 8 tu\u1ea7n\/l\u1ea7n \u0111\u01b0\u1ee3c c\u1ea5p ph\u00e9p cho \u0111i\u1ec1u tr\u1ecb hen n\u1eb7ng c\u00f3 t\u0103ng b\u1ea1ch c\u1ea7u \u00e1i toan<\/h2>\n<p>Farensa \u0111\u01b0\u1ee3c d\u00f9ng v\u1edbi li\u1ec1u ti\u00eam d\u01b0\u1edbi da kh\u1edfi \u0111\u1ea7u 4 tu\u1ea7n\/l\u1ea7n cho 3 li\u1ec1u \u0111\u1ea7u, sau \u0111\u00f3 8 tu\u1ea7n\/l\u1ea7n cho c\u00e1c li\u1ec1u sau.<br \/>\nHen c\u00f3 t\u0103ng b\u1ea1ch c\u1ea7u \u00e1i toan khi\u1ebfn cho b\u1ec7nh nh\u00e2n b\u1ecb gi\u1edbi h\u1ea1n c\u00e1c l\u1ef1a ch\u1ecdn \u0111i\u1ec1u tr\u1ecb v\u00e0 th\u01b0\u1eddng ph\u1ee5 thu\u1ed9c v\u00e0o steroid \u0111\u01b0\u1eddng u\u1ed1ng \u0111\u1ec3 x\u1eed tr\u00ed tri\u1ec7u ch\u1ee9ng, \u0111i\u1ec1u n\u00e0y c\u00f3 th\u1ec3 d\u1eabn t\u1edbi c\u00e1c t\u00e1c d\u1ee5ng kh\u00f4ng mong mu\u1ed1n nghi\u00eam tr\u1ecdng. Trong tu\u1ea7n n\u00e0y, FDA \u0111\u00e3 c\u1ea5p ph\u00e9p cho thu\u1ed1c Fasenra (benralizumab) c\u1ee7a h\u00e3ng AstraZeneca, m\u1ed9t kh\u00e1ng th\u1ec3 \u0111\u01a1n d\u00f2ng v\u1edbi th\u1ee5 th\u1ec3 interleukin 5 trong h\u1ed7 tr\u1ee3 \u0111i\u1ec1u tr\u1ecb duy tr\u00ec hen n\u1eb7ng c\u00f3 t\u0103ng b\u1ea1ch c\u1ea7u \u00e1i toan. Trong c\u00e1c nghi\u00ean c\u1ee9u, Fasenra cho th\u1ea5y l\u00e0m gi\u1ea3m t\u1ec9 l\u1ec7 c\u01a1n hen c\u1ea5p h\u00e0ng n\u0103m l\u00ean \u0111\u1ebfn 51% so v\u1edbi gi\u1ea3 d\u01b0\u1ee3c. C\u00e1c k\u1ebft qu\u1ea3 kh\u00e1c bao g\u1ed3m s\u1ef1 c\u1ea3i thi\u1ec7n c\u00f3 \u00fd ngh\u0129a ch\u1ee9c n\u0103ng th\u00f4ng kh\u00ed ph\u1ed5i (FEV1), gi\u1ea3m 75% trung v\u1ecb s\u1ed1 l\u1ea7n s\u1eed d\u1ee5ng steroid \u0111\u01b0\u1eddng u\u1ed1ng v\u00e0 t\u1ec9 l\u1ec7 ng\u1eebng s\u1eed d\u1ee5ng steroid \u0111\u01b0\u1eddng u\u1ed1ng l\u00e0 52%, v\u1edbi d\u1eef li\u1ec7u c\u00f3 l\u1ee3i v\u1ec1 c\u00e1c t\u00e1c d\u1ee5ng kh\u00f4ng mong mu\u1ed1n.<\/p>\n<h2>Heplisav, v\u1eafc-xin 2 li\u1ec1u trong d\u1ef1 ph\u00f2ng vi\u00eam gan B<\/h2>\n<p>T\u00e1c d\u1ee5ng kh\u00f4ng mong mu\u1ed1n hay g\u1eb7p nh\u1ea5t l\u00e0 \u0111au t\u1ea1i v\u1ecb tr\u00ed ti\u00eam, m\u1ec7t m\u1ecfi v\u00e0 \u0111au \u0111\u1ea7u.<br \/>\nN\u0103m 2015, s\u1ed1 tr\u01b0\u1eddng h\u1ee3p vi\u00eam gan B c\u1ea5p t\u00ednh \u0111\u00e3 gia t\u0103ng t\u1edbi h\u01a1n 20% tr\u00ean to\u00e0n n\u01b0\u1edbc M\u1ef9. Tuy nhi\u00ean, \u0111\u00e2y l\u00e0 b\u1ec7nh c\u00f3 th\u1ec3 d\u1ef1 ph\u00f2ng b\u1eb1ng c\u00e1ch ti\u00eam ch\u1ee7ng. Hi\u1ec7n nay FDA \u0111\u00e3 c\u1ea5p ph\u00e9p Heplisav c\u1ee7a h\u00e3ng Dynavax (V\u1eafc-xin vi\u00eam gan B t\u00e1i t\u1ed5 h\u1ee3p c\u00f3 tr\u1ee3 ch\u1ea5t) \u0111\u1ec3 d\u1ef1 ph\u00f2ng nhi\u1ec5m virus vi\u00eam gan B \u1edf t\u1ea5t c\u1ea3 c\u00e1c d\u01b0\u1edbi typ \u1edf ng\u01b0\u1eddi tr\u01b0\u1edfng th\u00e0nh t\u1eeb 18 tu\u1ed5i tr\u1edf l\u00ean. Heplisav-B l\u00e0 v\u1eafc-xin vi\u00eam gan B m\u1edbi \u0111\u1ea7u ti\u00ean \u1edf Hoa K\u00ec trong h\u01a1n 25 n\u0103m qua v\u00e0 l\u00e0 v\u1eafc-xin vi\u00eam gan B duy nh\u1ea5t d\u00f9ng hai li\u1ec1u \u1edf ng\u01b0\u1eddi tr\u01b0\u1edfng th\u00e0nh.<\/p>\n<h2>Civanti, thu\u1ed1c kh\u00f4ng ch\u1ee9a polysorbate 80 \u0111i\u1ec1u tr\u1ecb bu\u1ed3n n\u00f4n, n\u00f4n do \u0111i\u1ec1u tr\u1ecb h\u00f3a ch\u1ea5t<\/h2>\n<p>Polysorbate 80 \u0111\u00e3 \u0111\u01b0\u1ee3c cho th\u1ea5y l\u00e0 c\u00f3 li\u00ean quan t\u1edbi c\u00e1c ph\u1ea3n \u1ee9ng qu\u00e1 m\u1eabn, trong \u0111\u00f3 c\u00f3 ph\u1ea3n v\u1ec7.<br \/>\nCivanti (aprepitant) l\u00e0 d\u1ea1ng b\u00e0o ch\u1ebf d\u00f9ng \u0111\u01b0\u1eddng t\u0129nh m\u1ea1ch c\u1ee7a aprepitant, ch\u1ea5t \u0111\u1ed1i kh\u00e1ng th\u1ee5 th\u1ec3 c\u1ee7a ch\u1ea5t P\/neurokinin-1 (NK 1), \u0111\u01b0\u1ee3c ch\u1ec9 \u0111\u1ecbnh trong d\u1ef1 ph\u00f2ng n\u00f4n v\u00e0 bu\u1ed3n n\u00f4n do \u0111i\u1ec1u tr\u1ecb h\u00f3a ch\u1ea5t \u1edf c\u1ea3 giai \u0111o\u1ea1n c\u1ea5p v\u00e0 giai \u0111o\u1ea1n mu\u1ed9n. Civanti c\u1ee7a h\u00e3ng Heron Pharmaceuticals l\u00e0 d\u1ea1ng b\u00e0o ch\u1ebf \u0111\u01b0\u1eddng t\u0129nh m\u1ea1ch \u0111\u1ea7u ti\u00ean ph\u00e2n ph\u1ed1i ho\u1ea1t ch\u1ea5t aprepitant m\u1ed9t c\u00e1ch tr\u1ef1c ti\u1ebfp. Thu\u1ed1c \u0111\u01b0\u1ee3c c\u1ea5p ph\u00e9p d\u1ef1a tr\u00ean c\u01a1 s\u1edf d\u1eef li\u1ec7u cho th\u1ea5y t\u00ednh t\u01b0\u01a1ng \u0111\u01b0\u01a1ng sinh h\u1ecdc c\u1ee7a Civanti so v\u1edbi Emend IV (fosaprepitant). Thu\u1ed1c s\u1ebd \u0111\u01b0\u1ee3c l\u01b0u h\u00e0nh t\u1eeb th\u00e1ng 1\/2018.<\/p>\n<h2>Prevymis li\u1ec1u duy nh\u1ea5t\/ng\u00e0y \u0111\u01b0\u1ee3c c\u1ea5p ph\u00e9p cho d\u1ef1 ph\u00f2ng nhi\u1ec5m cytomegalovirus (CMV)<\/h2>\n<p>Nhi\u1ec5m CMV l\u00e0 lo\u1ea1i nhi\u1ec5m virus c\u00f3 th\u1ec3 r\u1ea5t n\u1eb7ng n\u1ec1 \u1edf b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c gh\u00e9p t\u1ebf b\u00e0o g\u1ed1c kh\u00e1c lo\u1ea1i t\u1eeb ng\u01b0\u1eddi cho t\u01b0\u01a1ng th\u00edch, b\u1ec7nh nh\u00e2n nh\u1eadn gh\u00e9p khi b\u1ecb nhi\u1ec5m CMV c\u00f3 nguy c\u01a1 cao b\u1ecb th\u1ea3i gh\u00e9p v\u00e0 t\u1eed vong.<\/p>\n<p>Trong tu\u1ea7n qua FDA \u0111\u00e3 c\u1ea5p ph\u00e9p cho thu\u1ed1c Prevymis (letermovir) c\u1ee7a h\u00e3ng Merck trong d\u1ef1 ph\u00f2ng nhi\u1ec5m CMV \u1edf nh\u00f3m b\u1ec7nh nh\u00e2n k\u1ec3 tr\u00ean. Premyvis l\u00e0 thu\u1ed1c \u1ee9c ch\u1ebf virus kh\u00f4ng ph\u1ea3i nucleosid theo c\u01a1 ch\u1ebf \u1ee9c ch\u1ebf s\u1ef1 nh\u00e2n l\u00ean c\u1ee7a virus th\u00f4ng qua \u0111\u00edch t\u00e1c d\u1ee5ng l\u00e0 ph\u1ee9c h\u1ee3p terminase c\u1ee7a virus. Trong c\u00e1c nghi\u00ean c\u1ee9u pivot, s\u1ed1 b\u1ec7nh nh\u00e2n nhi\u1ec5m CMV hay ph\u1ea3i ng\u1eebng \u0111i\u1ec1u tr\u1ecb \u1edf nh\u00f3m Premyvis \u00edt h\u01a1n c\u00f3 \u00fd ngh\u0129a (38%, n=122\/325) so v\u1edbi nh\u00f3m d\u00f9ng gi\u1ea3 d\u01b0\u1ee3c (63%, n=103\/170). Prevymis \u0111\u01b0\u1ee3c c\u1ea5p ph\u00e9p d\u01b0\u1edbi 2 d\u1ea1ng li\u1ec1u: d\u1ea1ng vi\u00ean n\u00e9n \u0111\u01b0\u1eddng u\u1ed1ng d\u00f9ng li\u1ec1u duy nh\u1ea5t\/ng\u00e0y v\u00e0 d\u1ea1ng ti\u00eam t\u0129nh m\u1ea1ch.<\/p>\n<p>Ngu\u1ed3n:\u00a0<a href=\"https:\/\/www.drugs.com\/newsletters\/weekly\/weekly-news-round-up-november-15-2017-1337.html\" rel=\"noopener\">https:\/\/www.drugs.com\/newsletters\/weekly\/weekly-news-round-up-november-15-2017-1337.html<\/a><\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Alibify MyCite: vi\u00ean n\u00e9n t\u00edch h\u1ee3p c\u1ea3m bi\u1ebfn nu\u1ed1t khi b\u1ec7nh nh\u00e2n d\u00f9ng thu\u1ed1c H\u1ec7 th\u1ed1ng n\u00e0y s\u1ebd g\u1eedi m\u1ed9t tin nh\u1eafn t\u1eeb c\u1ea3m bi\u1ebfn tr\u00ean vi\u00ean thu\u1ed1c \u0111\u1ebfn m\u1ed9t mi\u1ebfng d\u00e1n \u0111eo tr\u00ean ng\u01b0\u1eddi, sau \u0111\u00f3 truy\u1ec1n t\u1edbi \u0111i\u1ec7n tho\u1ea1i th\u00f4ng minh. Ng\u01b0\u1eddi ta \u01b0\u1edbc t\u00ednh r\u1eb1ng vi\u1ec7c b\u1ec7nh nh\u00e2n kh\u00f4ng tu\u00e2n th\u1ee7 theo [&#8230;]\n","protected":false},"author":1,"featured_media":4069,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-4185","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\/4185","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=4185"}],"version-history":[{"count":0,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/posts\/4185\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/media\/4069"}],"wp:attachment":[{"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/media?parent=4185"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/categories?post=4185"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/tags?post=4185"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}