{"id":737,"date":"2026-07-23T23:21:00","date_gmt":"2026-07-23T14:21:00","guid":{"rendered":"https:\/\/onepress.co.kr\/index.php\/briefing\/2026-07-23-lipfendra-oral-pcsk9-fda-2026-vi\/"},"modified":"2026-07-23T23:21:00","modified_gmt":"2026-07-23T14:21:00","slug":"2026-07-23-lipfendra-oral-pcsk9-fda-2026-vi","status":"publish","type":"briefing","link":"https:\/\/onepress.co.kr\/index.php\/briefing\/2026-07-23-lipfendra-oral-pcsk9-fda-2026-vi\/","title":{"rendered":"FDA duy\u1ec7t thu\u1ed1c \u1ee9c ch\u1ebf PCSK9 u\u1ed1ng \u0111\u1ea7u ti\u00ean, th\u00eam l\u1ef1a ch\u1ecdn gi\u1ea3m LDL-C"},"content":{"rendered":"

2026-07-23 23:18 KST<\/strong><\/p>\n

FDA cho bi\u1ebft ng\u00e0y 17\/7\/2026 r\u1eb1ng Lipfendra (enlicitide) \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t c\u00f9ng ch\u1ebf \u0111\u1ed9 \u0103n v\u00e0 v\u1eadn \u0111\u1ed9ng \u0111\u1ec3 gi\u1ea3m LDL-C \u1edf ng\u01b0\u1eddi l\u1edbn b\u1ecb t\u0103ng cholesterol m\u00e1u. Thay \u0111\u1ed5i ch\u00ednh l\u00e0 thu\u1ed1c u\u1ed1ng PCSK9 \u0111\u1ea7u ti\u00ean trong nh\u00f3m v\u1ed1n ch\u1ee7 y\u1ebfu l\u00e0 thu\u1ed1c ti\u00eam, kh\u00f4ng ph\u1ea3i b\u1eb1ng ch\u1ee9ng gi\u1ea3m bi\u1ebfn c\u1ed1 tim m\u1ea1ch.<\/p>\n

Ai b\u1ecb \u1ea3nh h\u01b0\u1edfng<\/h2>\n

Ph\u00ea duy\u1ec7t \u00e1p d\u1ee5ng cho ng\u01b0\u1eddi l\u1edbn t\u0103ng cholesterol m\u00e1u c\u1ea7n gi\u1ea3m LDL-C c\u00f9ng ch\u1ebf \u0111\u1ed9 \u0103n v\u00e0 v\u1eadn \u0111\u1ed9ng, bao g\u1ed3m ng\u01b0\u1eddi c\u00f3 heterozygous familial hypercholesterolemia. FDA m\u00f4 t\u1ea3 \u0111\u00e2y l\u00e0 l\u1ef1a ch\u1ecdn b\u1ed5 sung cho ng\u01b0\u1eddi l\u1edbn c\u1ea7n gi\u1ea3m LDL-C th\u00eam d\u00f9 \u0111\u00e3 d\u00f9ng \u0111i\u1ec1u tr\u1ecb hi\u1ec7n c\u00f3. Kh\u00f4ng n\u00ean t\u1ef1 b\u1eaft \u0111\u1ea7u thu\u1ed1c; b\u00e1c s\u0129 c\u1ea7n so s\u00e1nh statin, ezetimibe, PCSK9 d\u1ea1ng ti\u00eam v\u00e0 nguy c\u01a1 t\u1ed5ng th\u1ec3.<\/p>\n

\u0110i\u1ec1u g\u00ec thay \u0111\u1ed5i<\/h2>\n

Lipfendra l\u00e0 vi\u00ean u\u1ed1ng \u1ee9c ch\u1ebf PCSK9 d\u00f9ng m\u1ed9t l\u1ea7n m\u1ed7i ng\u00e0y. FDA n\u00f3i tr\u01b0\u1edbc \u0111\u00e2y PCSK9 inhibitors ch\u1ec9 c\u00f3 d\u1ea1ng ti\u00eam v\u00e0 Lipfendra l\u00e0 thu\u1ed1c u\u1ed1ng \u0111\u1ea7u ti\u00ean ch\u1eb7n PCSK9. Merck cho bi\u1ebft vi\u00ean \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t l\u00e0 20 mg. Ph\u1ea1m vi l\u00e0 ph\u00ea duy\u1ec7t c\u1ee7a FDA Hoa K\u1ef3; ph\u00ea duy\u1ec7t v\u00e0 chi tr\u1ea3 \u1edf n\u01b0\u1edbc kh\u00e1c c\u1ea7n ki\u1ec3m tra ri\u00eang.<\/p>\n

\"H\u00ecnh
H\u00ecnh \u1ea3nh do ONEPRESS t\u1ea1o: minh h\u1ecda x\u00e9t nghi\u1ec7m LDL, t\u01b0 v\u1ea5n nguy c\u01a1 tim m\u1ea1ch v\u00e0 kh\u00e1i ni\u1ec7m l\u1ef1a ch\u1ecdn PCSK9 \u0111\u01b0\u1eddng u\u1ed1ng. \u0110\u00e2y kh\u00f4ng ph\u1ea3i h\u00ecnh qu\u1ea3ng b\u00e1 s\u1ea3n ph\u1ea9m.<\/figcaption><\/figure>\n

B\u1eb1ng ch\u1ee9ng<\/h2>\n

Trang thu\u1ed1c ng\u01b0\u1eddi c\u1ee7a FDA cho bi\u1ebft hi\u1ec7u qu\u1ea3 v\u00e0 an to\u00e0n \u0111\u01b0\u1ee3c ch\u1ee9ng minh trong hai th\u1eed nghi\u1ec7m randomized, double-blind, placebo-controlled, NCT05952856 v\u00e0 NCT05952869, v\u1edbi 3.207 ng\u01b0\u1eddi l\u1edbn. \u1ede tu\u1ea7n 24, LDL-C thay \u0111\u1ed5i -56% so v\u1edbi placebo trong th\u1eed nghi\u1ec7m \u0111\u1ea7u v\u00e0 -59% \u1edf th\u1eed nghi\u1ec7m HeFH. Merck g\u1ecdi c\u00e1c nghi\u00ean c\u1ee9u n\u00e0y l\u00e0 CORALreef Lipids v\u00e0 CORALreef HeFH.<\/p>\n

Gi\u1edbi h\u1ea1n v\u00e0 l\u01b0u \u00fd<\/h2>\n

Gi\u1edbi h\u1ea1n quan tr\u1ecdng l\u00e0 ph\u00ea duy\u1ec7t d\u1ef1a tr\u00ean gi\u1ea3m LDL-C. T\u00e0i li\u1ec7u \u0111\u00e3 ki\u1ec3m tra kh\u00f4ng ch\u1ee9ng minh thu\u1ed1c gi\u1ea3m nh\u1ed3i m\u00e1u c\u01a1 tim, \u0111\u1ed9t qu\u1ef5 hay t\u1eed vong. FDA ghi nh\u1eadn ti\u00eau ch\u1ea3y v\u00e0 ch\u00f3ng m\u1eb7t nhi\u1ec1u h\u01a1n placebo \u1edf ng\u01b0\u1eddi l\u1edbn HeFH. V\u00ec cholesterol cao th\u01b0\u1eddng kh\u00f4ng c\u00f3 tri\u1ec7u ch\u1ee9ng, x\u00e9t nghi\u1ec7m m\u00e1u v\u00e0 \u0111\u00e1nh gi\u00e1 nguy c\u01a1 tim m\u1ea1ch to\u00e0n di\u1ec7n ph\u1ea3i \u0111i tr\u01b0\u1edbc.<\/p>\n

Ngu\u1ed3n ki\u1ec3m tra<\/h2>\n

Th\u00f4ng c\u00e1o FDA x\u00e1c nh\u1eadn ng\u00e0y ph\u00ea duy\u1ec7t, ch\u1ec9 \u0111\u1ecbnh v\u00e0 ph\u1ea1m vi PCSK9 u\u1ed1ng \u0111\u1ea7u ti\u00ean. Trang thu\u1ed1c ng\u01b0\u1eddi c\u1ee7a FDA cung c\u1ea5p c\u1ee1 m\u1eabu, s\u1ed1 th\u1eed nghi\u1ec7m, m\u1ee9c gi\u1ea3m LDL-C tu\u1ea7n 24 v\u00e0 an to\u00e0n. Th\u00f4ng b\u00e1o Merck gi\u00fap \u0111\u1ed1i chi\u1ebfu h\u00e0m l\u01b0\u1ee3ng vi\u00ean v\u00e0 t\u00ean th\u1eed nghi\u1ec7m CORALreef.<\/p>\n

Ngu\u1ed3n ch\u00ednh th\u1ee9c<\/h2>\n

FDA: ng\u00e0y ph\u00ea duy\u1ec7t, ch\u1ec9 \u0111\u1ecbnh v\u00e0 ph\u1ea1m vi PCSK9 u\u1ed1ng \u0111\u1ea7u ti\u00ean<\/a><\/p>\n

FDA thu\u1ed1c ng\u01b0\u1eddi: c\u1ee1 th\u1eed nghi\u1ec7m, gi\u1ea3m LDL-C tu\u1ea7n 24 v\u00e0 an to\u00e0n<\/a><\/p>\n

Merck: h\u00e0m l\u01b0\u1ee3ng vi\u00ean v\u00e0 t\u00ean th\u1eed nghi\u1ec7m CORALreef<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

FDA cho bi\u1ebft ng\u00e0y 17\/7\/2026 r\u1eb1ng Lipfendra (enlicitide) \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t c\u00f9ng ch\u1ebf \u0111\u1ed9 \u0103n v\u00e0 v\u1eadn \u0111\u1ed9ng \u0111\u1ec3 gi\u1ea3m LDL-C \u1edf ng\u01b0\u1eddi l\u1edbn b\u1ecb t\u0103ng cholesterol m\u00e1u. Thay \u0111\u1ed5i ch\u00ednh l\u00e0 thu\u1ed1c u\u1ed1ng PCSK9 \u0111\u1ea7u ti\u00ean trong nh\u00f3m v\u1ed1n ch\u1ee7 y\u1ebfu l\u00e0 thu\u1ed1c ti\u00eam, kh\u00f4ng ph\u1ea3i b\u1eb1ng ch\u1ee9ng gi\u1ea3m bi\u1ebfn c\u1ed1 tim m\u1ea1ch.<\/p>\n","protected":false},"featured_media":0,"template":"","meta":[],"class_list":["post-737","briefing","type-briefing","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/onepress.co.kr\/index.php\/wp-json\/wp\/v2\/briefing\/737","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/onepress.co.kr\/index.php\/wp-json\/wp\/v2\/briefing"}],"about":[{"href":"https:\/\/onepress.co.kr\/index.php\/wp-json\/wp\/v2\/types\/briefing"}],"wp:attachment":[{"href":"https:\/\/onepress.co.kr\/index.php\/wp-json\/wp\/v2\/media?parent=737"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}