{"id":739,"date":"2026-07-23T23:22:00","date_gmt":"2026-07-23T14:22:00","guid":{"rendered":"https:\/\/onepress.co.kr\/index.php\/briefing\/2026-07-23-casgevy-age-2-expanded-approval-ko\/"},"modified":"2026-07-23T23:22:00","modified_gmt":"2026-07-23T14:22:00","slug":"2026-07-23-casgevy-age-2-expanded-approval-ko","status":"publish","type":"briefing","link":"https:\/\/onepress.co.kr\/index.php\/briefing\/2026-07-23-casgevy-age-2-expanded-approval-ko\/","title":{"rendered":"Casgevy\uac00 2\uc138 \uc774\uc0c1\uc73c\ub85c \ud655\ub300\ub410\ub2e4: CRISPR \uce58\ub8cc\uac00 \ub354 \uc5b4\ub9b0 \ud658\uc790\uc5d0\uac8c \uc5f4\ub838\ub2e4"},"content":{"rendered":"

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

\ubbf8\uad6d FDA\ub294 2026\ub144 7\uc6d4 1\uc77c Casgevy(exagamglogene autotemcel)\ub97c 2\uc138 \uc774\uc0c1 sickle cell disease\uc640 transfusion-dependent beta thalassemia \uc77c\ubd80 \ud658\uc790\uc5d0\uac8c \ud655\ub300 \uc2b9\uc778\ud588\ub2e4. \ud575\uc2ec\uc740 \uae30\uc874 12\uc138 \uc774\uc0c1 \uc911\uc2ec\uc774\ub358 CRISPR \uae30\ubc18 \uc720\uc804\uc790\uce58\ub8cc\uc758 \ubbf8\uad6d \uc801\uc751\uc99d\uc774 \ud6e8\uc52c \uc5b4\ub9b0 \uc18c\uc544\ub85c \ub0b4\ub824\uac14\ub2e4\ub294 \uc810\uc774\uba70, \ubaa8\ub4e0 \ud658\uc790\uac00 \ubc14\ub85c \ubc1b\uc744 \uc218 \uc788\ub294 \uac04\ub2e8\ud55c \uce58\ub8cc\ub294 \uc544\ub2c8\ub2e4.<\/p>\n

\ub204\uac00 \uc601\ud5a5\uc744 \ubc1b\ub098<\/h2>\n

\uc2b9\uc778 \ub300\uc0c1\uc740 2\uc138 \uc774\uc0c1 \ud658\uc790 \uc911 recurrent vaso-occlusive crises\uac00 \uc788\ub294 sickle cell disease(SCD) \ub610\ub294 transfusion-dependent beta thalassemia(TDT)\ub97c \uac00\uc9c4 \uc0ac\ub78c\uc774\ub2e4. FDA\ub294 Casgevy\uac00 \uc774\uc804\uc5d0\ub294 SCD \ub610\ub294 TDT\uc758 12\uc138 \uc774\uc0c1 \ud658\uc790 \uce58\ub8cc\ub85c \uc2b9\uc778\ub3fc \uc788\uc5c8\ub2e4\uace0 \uc124\uba85\ud55c\ub2e4. \uc774\ubc88 \ud655\ub300\ub294 \ud2b9\ud788 \uc5b4\ub9b0 \ud658\uc790 \uac00\uc871\uc5d0\uac8c \uc758\ubbf8\uac00 \uc788\uc9c0\ub9cc, \uc720\uc804\uc790\ud615, \uc9c8\ubcd1 \uc911\uc99d\ub3c4, \uc774\uc2dd \uac00\ub2a5\uc131, \uc804\ubb38 \uce58\ub8cc\uc13c\ud130 \uc811\uadfc\uc131\uc774 \ubaa8\ub450 \uad00\uac74\uc774\ub2e4.<\/p>\n

\ubb34\uc5c7\uc774 \uc5b8\uc81c \ub2ec\ub77c\uc9c0\ub098<\/h2>\n

FDA\ub294 2026\ub144 7\uc6d4 1\uc77c supplemental approval\uc744 \ub0c8\ub2e4. FDA\uc758 Casgevy \uc81c\ud488 \ud398\uc774\uc9c0\ub3c4 STN 125787 \uc801\uc751\uc99d\uc744 2\uc138 \uc774\uc0c1 SCD with recurrent VOCs\uc640 TDT\ub85c \ud45c\uc2dc\ud55c\ub2e4. FDA \ubcf4\ub3c4\uc790\ub8cc\ub294 \uc774\uac83\uc774 2\uc138 \uc774\uc0c1 SCD \ud658\uc790\uc5d0\uac8c \uc2b9\uc778\ub41c \uccab gene therapy\ub77c\uace0 \uc124\uba85\ud55c\ub2e4. Vertex\ub294 SCD\uc640 TDT \ubaa8\ub450\uc5d0\uc11c 2\uc138\uae4c\uc9c0 \ub0b4\ub824\uac04 \uccab \uc2b9\uc778 \uc720\uc804 \uce58\ub8cc\ub77c\uace0 \ubc1d\ud614\ub2e4.<\/p>\n

\"\uc18c\uc544
\uc81c\uc791 \uc774\ubbf8\uc9c0: ONEPRESS\uac00 \uc18c\uc544 \ud608\uc561\uc9c8\ud658 \uc0c1\ub2f4\uacfc \uc790\uac00 \uc870\ud608\ubaa8\uc138\ud3ec CRISPR \ud3b8\uc9d1 \uce58\ub8cc \uacbd\ub85c\ub97c \uc124\uba85\uc6a9\uc73c\ub85c \uad6c\uc131\ud588\ub2e4. \uc2e4\uc81c \uce58\ub8cc \uc7a5\uba74\uc774\ub098 \ud2b9\uc815 \uc81c\ud488 \ud64d\ubcf4\uac00 \uc544\ub2c8\ub2e4.<\/figcaption><\/figure>\n

\uce58\ub8cc\uac00 \ubb34\uc5c7\uc778\uc9c0<\/h2>\n

Casgevy\ub294 \ud658\uc790 \uc790\uc2e0\uc758 hematopoietic stem cells\ub97c \ucc44\ucde8\ud574 CRISPR\/Cas9\ub85c \ud3b8\uc9d1\ud55c \ub4a4 \ud55c \ubc88 \uc815\ub9e5 \uc8fc\uc785\ud558\ub294 autologous cell therapy\ub2e4. FDA\ub294 \ud3b8\uc9d1\ub41c \uc138\ud3ec\uac00 \uace8\uc218\uc5d0 \uc790\ub9ac \uc7a1\ub294 \ubc29\uc2dd\uc774\ub77c\uace0 \uc124\uba85\ud55c\ub2e4. \uadf8\ub798\uc11c \uc77c\ubc18 \ucc98\ubc29\uc57d\ucc98\ub7fc \uc57d\uad6d\uc5d0\uc11c \ubc1b\uc544 \ubcf5\uc6a9\ud558\ub294 \uce58\ub8cc\uac00 \uc544\ub2c8\ub77c, \uc138\ud3ec \ucc44\ucde8, conditioning, \uc785\uc6d0 \ub610\ub294 \uc9d1\uc911 \uad00\ub9ac, \uc7a5\uae30 \ucd94\uc801\uc774 \ud544\uc694\ud55c \uacbd\ub85c\ub2e4.<\/p>\n

\uc608\uc678\uc640 \uc8fc\uc758\uc0ac\ud56d<\/h2>\n

\uc774\ubc88 \uc2b9\uc778\uc740 \ubbf8\uad6d \uae30\uc900\uc774\uba70, \ub2e4\ub978 \uad6d\uac00\uc758 \uc5f0\ub839\u00b7\uc9c8\ud658 \uc801\uc751\uc99d\uc740 \uac19\uc9c0 \uc54a\uc744 \uc218 \uc788\ub2e4. \ubaa8\ub4e0 SCD\ub098 TDT \uc5b4\ub9b0\uc774\uac00 \ub300\uc0c1\uc774\ub77c\ub294 \ub73b\ub3c4 \uc544\ub2c8\ub2e4. \uce58\ub8cc \uc804\uc5d0\ub294 \uc9c8\ubcd1 \uae30\uc900, \uae30\uc874 \uce58\ub8cc \ubc18\uc751, \uac10\uc5fc\u00b7\uc774\uc2dd \uc704\ud5d8, \uc0dd\uc2dd\ub2a5 \ubcf4\uc874 \uc0c1\ub2f4, \uc7a5\uae30 \ucd94\uc801 \uacc4\ud68d\uc744 \uc804\ubb38\uc13c\ud130\uc5d0\uc11c \ud655\uc778\ud574\uc57c \ud55c\ub2e4. FDA \uc81c\ud488 \ud398\uc774\uc9c0\uc758 approval letters\uc640 package insert\uac00 \uc2e4\uc81c \ud310\ub2e8\uc758 \ucd9c\ubc1c\uc810\uc774\ub2e4.<\/p>\n

\uacf5\uc2dd \ud655\uc778 \uacbd\ub85c<\/h2>\n

FDA \ubcf4\ub3c4\uc790\ub8cc\uc5d0\uc11c\ub294 \uc2b9\uc778\uc77c, 2\uc138 \uc774\uc0c1 \ud655\ub300, \uccab \uc18c\uc544 SCD gene therapy \ubc94\uc704\ub97c \ud655\uc778\ud55c\ub2e4. FDA Casgevy \uc81c\ud488 \ud398\uc774\uc9c0\uc5d0\uc11c\ub294 STN 125787 \uc801\uc751\uc99d\uacfc \uc81c\ud488 \uc790\ub8cc, 2026\ub144 7\uc6d4 1\uc77c \uc2b9\uc778 \uc11c\ud55c\uc744 \ud655\uc778\ud55c\ub2e4. Vertex \ubc1c\ud45c\uc5d0\uc11c\ub294 \uc81c\uc870\uc0ac \uce21 \ucd94\uac00 \ub300\uc0c1 \uaddc\ubaa8\uc640 SCD\/TDT \ud45c\ud604\uc744 \ub300\uc870\ud55c\ub2e4.<\/p>\n

\uacf5\uc2dd \ucd9c\ucc98<\/h2>\n

FDA \ubcf4\ub3c4\uc790\ub8cc\uc5d0\uc11c \uc2b9\uc778\uc77c, 2\uc138 \uc774\uc0c1 \ud655\ub300, \uccab \uc18c\uc544 SCD gene therapy \ubc94\uc704 \ud655\uc778<\/a><\/p>\n

FDA Casgevy \uc81c\ud488 \ud398\uc774\uc9c0\uc5d0\uc11c STN 125787 \uc801\uc751\uc99d\uacfc \uc2b9\uc778 \ubb38\uc11c \ud655\uc778<\/a><\/p>\n

Vertex \ubc1c\ud45c\uc5d0\uc11c \uc81c\uc870\uc0ac \uce21 \ud655\ub300 \uc801\uc751\uc99d \uc124\uba85 \ud655\uc778<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

\ubbf8\uad6d FDA\ub294 2026\ub144 7\uc6d4 1\uc77c Casgevy(exagamglogene autotemcel)\ub97c 2\uc138 \uc774\uc0c1 sickle cell disease\uc640 transfusion-dependent beta thalassemia \uc77c\ubd80 \ud658\uc790\uc5d0\uac8c \ud655\ub300 \uc2b9\uc778\ud588\ub2e4. \ud575\uc2ec\uc740 \uae30\uc874 12\uc138 \uc774\uc0c1 \uc911\uc2ec\uc774\ub358 CRISPR \uae30\ubc18 \uc720\uc804\uc790\uce58\ub8cc\uc758 \ubbf8\uad6d \uc801\uc751\uc99d\uc774 \ud6e8\uc52c \uc5b4\ub9b0 \uc18c\uc544\ub85c \ub0b4\ub824\uac14\ub2e4\ub294 \uc810\uc774\uba70, \ubaa8\ub4e0 \ud658\uc790\uac00 \ubc14\ub85c \ubc1b\uc744 \uc218 \uc788\ub294 \uac04\ub2e8\ud55c \uce58\ub8cc\ub294 \uc544\ub2c8\ub2e4.<\/p>\n","protected":false},"featured_media":0,"template":"","meta":[],"class_list":["post-739","briefing","type-briefing","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/onepress.co.kr\/index.php\/wp-json\/wp\/v2\/briefing\/739","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=739"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}