{"id":733,"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-ko\/"},"modified":"2026-07-23T23:21:00","modified_gmt":"2026-07-23T14:21:00","slug":"2026-07-23-lipfendra-oral-pcsk9-fda-2026-ko","status":"publish","type":"briefing","link":"https:\/\/onepress.co.kr\/index.php\/briefing\/2026-07-23-lipfendra-oral-pcsk9-fda-2026-ko\/","title":{"rendered":"\uccab \uacbd\uad6c PCSK9 \uc5b5\uc81c\uc81c Lipfendra \uc2b9\uc778, LDL \uce58\ub8cc \uc120\ud0dd\uc9c0\uac00 \ub2ec\ub77c\uc84c\ub2e4"},"content":{"rendered":"<p><strong>2026-07-23 23:18 KST<\/strong><\/p>\n<p>\ubbf8\uad6d FDA\ub294 2026\ub144 7\uc6d4 17\uc77c Lipfendra(enlicitide)\ub97c \uc131\uc778 \uace0\ucf5c\ub808\uc2a4\ud14c\ub864\ud608\uc99d\uc758 LDL-C \uac10\uc18c \ubcf4\uc870 \uce58\ub8cc\ub85c \uc2b9\uc778\ud588\ub2e4\uace0 \ubc1d\ud614\ub2e4. \ud575\uc2ec\uc740 \uc9c0\uae08\uae4c\uc9c0 \uc8fc\uc0ac\uc81c\uac00 \uc911\uc2ec\uc774\ub358 PCSK9 \uc5b5\uc81c\uc81c \uacc4\uc5f4\uc5d0 \ud558\ub8e8 \ud55c \ubc88 \uba39\ub294 \uacbd\uad6c\uc81c\uac00 \ucc98\uc74c \ucd94\uac00\ub410\ub2e4\ub294 \uc810\uc774\uba70, \uc2ec\ud608\uad00 \uc0ac\uac74 \uac10\uc18c\uac00 \ud655\uc778\ub410\ub2e4\ub294 \ub73b\uc740 \uc544\ub2c8\ub2e4.<\/p>\n<h2>\ub204\uac00 \uc601\ud5a5\uc744 \ubc1b\ub098<\/h2>\n<p>\uc2b9\uc778 \ub300\uc0c1\uc740 \uc2dd\uc774\uc694\ubc95\uacfc \uc6b4\ub3d9\uc5d0 \ub354\ud574 LDL-C\ub97c \ub0ae\ucdb0\uc57c \ud558\ub294 \uc131\uc778 \uace0\ucf5c\ub808\uc2a4\ud14c\ub864\ud608\uc99d \ud658\uc790\uc774\uba70, heterozygous familial hypercholesterolemia(HeFH)\ub3c4 \ud3ec\ud568\ub41c\ub2e4. FDA\ub294 \uae30\uc874 \uce58\ub8cc\uc5d0\ub3c4 \ucd94\uac00 LDL-C \uac10\uc18c\uac00 \ud544\uc694\ud55c \uc131\uc778\uc5d0\uac8c \uc120\ud0dd\uc9c0\ub97c \uc81c\uacf5\ud55c\ub2e4\uace0 \uc124\uba85\ud55c\ub2e4. \uac1c\uc778\uc774 \ubc14\ub85c \ubcf5\uc6a9\uc744 \uacb0\uc815\ud560 \uc0ac\uc548\uc740 \uc544\ub2c8\uba70, \uae30\uc874 statin, ezetimibe, \uc8fc\uc0ac\ud615 PCSK9 \uce58\ub8cc\uc640 \ud568\uaed8 \uc758\ub8cc\uc9c4\uc774 \uc704\ud5d8\ub3c4\ub97c \ud310\ub2e8\ud574\uc57c \ud55c\ub2e4.<\/p>\n<h2>\ubb34\uc5c7\uc774 \uc5b8\uc81c \ub2ec\ub77c\uc9c0\ub098<\/h2>\n<p>Lipfendra\ub294 \ud558\ub8e8 \ud55c \ubc88 \uba39\ub294 \uc815\uc81c \ud615\ud0dc\uc758 PCSK9 \uc5b5\uc81c\uc81c\ub2e4. FDA\ub294 PCSK9 \uc5b5\uc81c\uc81c\uac00 \uae30\uc874\uc5d0\ub294 \uc8fc\uc0ac\uc81c\ub85c\ub9cc \uc81c\uacf5\ub410\uace0, \uc774\ubc88 \uc2b9\uc778\uc774 \ucc98\uc74c \uacbd\uad6c PCSK9 \ucc28\ub2e8 \uc57d\uc774\ub77c\uace0 \uc124\uba85\ud588\ub2e4. Merck\ub294 20mg \uc815\uc81c\ub85c \uc2b9\uc778\ub410\ub2e4\uace0 \ubc1d\ud614\ub2e4. \uc801\uc6a9 \ubc94\uc704\ub294 \ubbf8\uad6d FDA \uc2b9\uc778 \uae30\uc900\uc774\uba70, \ub2e4\ub978 \uad6d\uac00\uc758 \uc2b9\uc778\u00b7\uae09\uc5ec \uc5ec\ubd80\ub294 \ubcc4\ub3c4\ub85c \ud655\uc778\ud574\uc57c \ud55c\ub2e4.<\/p>\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" src=\"https:\/\/onepress.co.kr\/wp-content\/uploads\/2026\/07\/lipfendra-oral-pcsk9-fda-2026-ko.png\" alt=\"\uc2ec\uc7a5\ub0b4\uacfc \uc0c1\ub2f4\uc2e4\uc5d0\uc11c LDL \uac80\uc0ac\uc640 \uacbd\uad6c \uce58\ub8cc \uc120\ud0dd\uc9c0\ub97c \uc124\uba85\ud558\ub294 \uc774\ubbf8\uc9c0\" loading=\"eager\" \/><figcaption class=\"op-briefing-image-caption\">\uc81c\uc791 \uc774\ubbf8\uc9c0: ONEPRESS\uac00 LDL \uac80\uc0ac, \uc2ec\ud608\uad00 \uc704\ud5d8 \uc0c1\ub2f4, \uacbd\uad6c PCSK9 \uce58\ub8cc \uc120\ud0dd\uc9c0\uc758 \uac1c\ub150\uc744 \uc124\uba85\uc6a9\uc73c\ub85c \uad6c\uc131\ud588\ub2e4. \ud2b9\uc815 \uc81c\ud488 \ud64d\ubcf4 \uc774\ubbf8\uc9c0\uac00 \uc544\ub2c8\ub2e4.<\/figcaption><\/figure>\n<h2>\ud575\uc2ec \uadfc\uac70<\/h2>\n<p>FDA\uc758 human-drug \ud398\uc774\uc9c0\ub294 \ub450 \uac1c\uc758 randomized, double-blind, placebo-controlled trial\uc5d0\uc11c \ucd1d 3,207\uba85\uc758 \uc131\uc778\uc744 \ud3c9\uac00\ud588\ub2e4\uace0 \uc124\uba85\ud55c\ub2e4. 24\uc8fc \uc2dc\uc810 LDL-C \ubcc0\ud654\uac00 \uccab \uc2dc\ud5d8\uc5d0\uc11c placebo \ub300\ube44 -56%, HeFH \ub300\uc0c1 \ub450 \ubc88\uc9f8 \uc2dc\ud5d8\uc5d0\uc11c -59%\uc600\ub2e4. Merck \ubc1c\ud45c\ub3c4 CORALreef Lipids\uc640 CORALreef HeFH \uacb0\uacfc\uac00 \uc2b9\uc778\uc758 \uadfc\uac70\ub77c\uace0 \ubc1d\ud78c\ub2e4.<\/p>\n<h2>\uc608\uc678\uc640 \uc8fc\uc758\uc0ac\ud56d<\/h2>\n<p>\uc911\uc694\ud55c \ud55c\uacc4\ub294 \uc774 \uc2b9\uc778\uc774 LDL-C \uac10\uc18c\ub97c \uadfc\uac70\ub85c \ud55c \uce58\ub8cc \uc120\ud0dd\uc9c0\ub77c\ub294 \uc810\uc774\ub2e4. \uc774\ubc88 \uc790\ub8cc\ub9cc\uc73c\ub85c \uc2ec\uadfc\uacbd\uc0c9, \ub1cc\uc878\uc911, \uc0ac\ub9dd \uac19\uc740 \uc2ec\ud608\uad00 \uc0ac\uac74\uc744 \uc904\uc778\ub2e4\uace0 \ub2e8\uc815\ud558\uba74 \uc548 \ub41c\ub2e4. FDA\ub294 HeFH \uc2dc\ud5d8\uc5d0\uc11c diarrhea\uc640 dizziness\uac00 placebo\ubcf4\ub2e4 \ub354 \ub9ce\uc774 \ub098\ud0c0\ub0ac\ub2e4\uace0 \uc124\uba85\ud55c\ub2e4. \uace0\ucf5c\ub808\uc2a4\ud14c\ub864\ud608\uc99d\uc740 \uc99d\uc0c1\uc774 \uc5c6\uc744 \uc218 \uc788\uc73c\ubbc0\ub85c \ud608\uc561\uac80\uc0ac\uc640 \uc804\uccb4 \uc704\ud5d8 \ud3c9\uac00\uac00 \uba3c\uc800\ub2e4.<\/p>\n<h2>\uacf5\uc2dd \ud655\uc778 \uacbd\ub85c<\/h2>\n<p>FDA \ubcf4\ub3c4\uc790\ub8cc\uc5d0\uc11c\ub294 \uc2b9\uc778\uc77c, \uc801\uc751\uc99d, \uccab \uacbd\uad6c PCSK9 \uc5b5\uc81c\uc81c\ub77c\ub294 \ubc94\uc704\ub97c \ud655\uc778\ud55c\ub2e4. FDA human-drug \ud398\uc774\uc9c0\uc5d0\uc11c\ub294 3,207\uba85, \ub450 \uc2dc\ud5d8 \ubc88\ud638, 24\uc8fc LDL-C \uac10\uc18c\uc728, \uc774\uc0c1\ubc18\uc751\uc744 \ud655\uc778\ud55c\ub2e4. Merck \ubc1c\ud45c\uc5d0\uc11c\ub294 \uc815\uc81c \uc6a9\ub7c9\uacfc CORALreef \uc2dc\ud5d8\uba85\uc744 \ub300\uc870\ud55c\ub2e4.<\/p>\n<h2>\uacf5\uc2dd \ucd9c\ucc98<\/h2>\n<p><a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-approves-first-oral-pcsk9-inhibitor-lower-ldl-cholesterol-adults-high-cholesterol\" target=\"_blank\" rel=\"noopener noreferrer\">FDA \ubcf4\ub3c4\uc790\ub8cc\uc5d0\uc11c \uc2b9\uc778\uc77c, \uc801\uc751\uc99d, \uccab \uacbd\uad6c PCSK9 \ubc94\uc704 \ud655\uc778<\/a><\/p>\n<p><a href=\"https:\/\/www.fda.gov\/drugs\/news-events-human-drugs\/fda-approves-first-oral-therapy-inhibits-proprotein-convertase-subtilisinkexin-type-9-pcsk9-lower\" target=\"_blank\" rel=\"noopener noreferrer\">FDA human-drug \ud398\uc774\uc9c0\uc5d0\uc11c \uc2dc\ud5d8 \uaddc\ubaa8, 24\uc8fc LDL-C \uac10\uc18c\uc728, \uc548\uc804\uc131 \ud655\uc778<\/a><\/p>\n<p><a href=\"https:\/\/www.merck.com\/news\/mercks-lipfendra-enlicitide-is-the-first-and-only-once-daily-oral-pcsk9-inhibitor-approved-by-the-u-s-fda-to-reduce-ldl-c-in-adults-with-hypercholesterolemia\/\" target=\"_blank\" rel=\"noopener noreferrer\">Merck \ubc1c\ud45c\uc5d0\uc11c \uc815\uc81c \uc6a9\ub7c9\uacfc CORALreef \uc2dc\ud5d8\uba85 \ud655\uc778<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\ubbf8\uad6d FDA\ub294 2026\ub144 7\uc6d4 17\uc77c Lipfendra(enlicitide)\ub97c \uc131\uc778 \uace0\ucf5c\ub808\uc2a4\ud14c\ub864\ud608\uc99d\uc758 LDL-C \uac10\uc18c \ubcf4\uc870 \uce58\ub8cc\ub85c \uc2b9\uc778\ud588\ub2e4\uace0 \ubc1d\ud614\ub2e4. \ud575\uc2ec\uc740 \uc9c0\uae08\uae4c\uc9c0 \uc8fc\uc0ac\uc81c\uac00 \uc911\uc2ec\uc774\ub358 PCSK9 \uc5b5\uc81c\uc81c \uacc4\uc5f4\uc5d0 \ud558\ub8e8 \ud55c \ubc88 \uba39\ub294 \uacbd\uad6c\uc81c\uac00 \ucc98\uc74c \ucd94\uac00\ub410\ub2e4\ub294 \uc810\uc774\uba70, \uc2ec\ud608\uad00 \uc0ac\uac74 \uac10\uc18c\uac00 \ud655\uc778\ub410\ub2e4\ub294 \ub73b\uc740 \uc544\ub2c8\ub2e4.<\/p>\n","protected":false},"featured_media":0,"template":"","meta":[],"class_list":["post-733","briefing","type-briefing","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/onepress.co.kr\/index.php\/wp-json\/wp\/v2\/briefing\/733","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=733"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}