{"id":62512,"date":"2021-06-16T00:10:24","date_gmt":"2021-06-15T22:10:24","guid":{"rendered":"https:\/\/gyrocarpus.com\/?p=62512"},"modified":"2022-06-18T02:12:21","modified_gmt":"2022-06-18T00:12:21","slug":"18%eb%85%84-%eb%a7%8c%ec%9d%98-%ec%b9%98%eb%a7%a4-%ec%8b%a0%ec%95%bd-6%ec%9b%94-7%ec%9d%bc-%eb%af%b8%ea%b5%ad-fda%ec%9d%98-%ec%95%84%eb%91%90%ec%b9%b4%eb%88%84%eb%a7%99aducanumab-%ec%8a%b9","status":"publish","type":"post","link":"https:\/\/gyrocarpus.com\/archives\/62512","title":{"rendered":"18\ub144 \ub9cc\uc758 \uce58\ub9e4 \uc2e0\uc57d – 6\uc6d4 7\uc77c, \ubbf8\uad6d FDA\uc758 \uc544\ub450\uce74\ub204\ub9d9(Aducanumab) \uc2b9\uc778"},"content":{"rendered":"\n
<\/div>\n\n\n\n

2003\ub144 \uba54\ub9cc\ud2f4 \uc774\ud6c4\ub85c 18\ub144\uc9f8 \uc0c8\ub85c\uc6b4 \uce58\ub9e4\uc57d\uc758 \ub3c4\ub798\ub97c \uae30\ub2e4\ub824 \uc654\ub294\ub370, \uae30\ub2e4\ub9bc\uc758 \ub05d\uc774 \uc654\uc2b5\ub2c8\ub2e4. \ub610\ud55c \uc5ed\uc0ac\uc0c1 \uac00\uc7a5 \ub17c\ub780\uc774 \ub9ce\uc740 \uc57d\ubb3c\ub85c \uae30\uc5b5\uc774 \ub420\uc9c0\ub3c4 \ubaa8\ub985\ub2c8\ub2e4. \uc0ac\uc774\uc5b8\uc2a4(Science)\uac00 \uc8fc\uc694 \uacfc\ud559 \uae30\uc220 \ud2b8\ub80c\ub4dc\ub85c \uc8fc\ubaa9\ud588\ub358 \uc54c\uce20\ud558\uc774\uba38 \uc2e0\uc57d\uc778 \ud56d \uc544\ubc00\ub85c\uc774\ub4dc \ubca0\ud0c0 \ub2e8\uc77c \ud56d\uccb4(\uc544\ub450\uce74\ub204\ub9d9, Aducanumab)\uac00 \uc8fc\uc778\uacf5\uc785\ub2c8\ub2e4. \ub4dc\ub514\uc5b4 \ubbf8\uad6d FDA\uac00 6\uc6d4 7\uc77c \uc544\ub450\ud5ec\ub984(Aduhelm)\uc774\ub77c\ub294 \uc81c\ud488\uba85\uc73c\ub85c \ud310\ub9e4 \uc2b9\uc778\uc744 \ud558\uc600\uc2b5\ub2c8\ub2e4. \uc720\ub7fd\uc5d0\uc11c\ub294 \uc62c\ud574 \ub9d0\uc5d0 \uc2b9\uc778\ub420 \uc608\uc815\uc785\ub2c8\ub2e4. \ubc14\uc774\uc624\uc820(Biogen)\uacfc \uc5d0\uc790\uc774(Eisai)\ub294 2017\ub144\ubd80\ud130 \uac1c\ubc1c\uacfc \uc0c1\uc5c5\ud654\ub97c \uc704\ud558\uc5ec \ucf5c\ub77c\ubcf4\ub97c \uc9c4\ud589\ud574\uc654\uc2b5\ub2c8\ub2e4. \uc5d0\uc790\uc774 \uc81c\uc57d \ud68c\uc0ac\ub294 \ub300\ud45c\uc801\uc778 \uae30\uc874 \uce58\ub9e4 \uc57d\uc778 ‘\uc544\ub9ac\uc149\ud2b8’\ub85c\ub3c4 \uc720\uba85\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n

\uc544\ub450\uce74\ub204\ub9d9\uc740 \uc54c\uce20\ud558\uc774\uba38 \uce58\ub9e4\uc758 \uc6d0\uc778 \ubb3c\uc9c8\uc778 \ubca0\ud0c0 \uc544\ubc00\ub85c\uc774\ub4dc\ub97c \ud0c0\uae43\uc73c\ub85c \uc0bc\ub294 \ud56d\uccb4\uc785\ub2c8\ub2e4. \uc774 \uc2e0\uc57d\uc740 \ub450 \uac00\uc9c0 \uce21\uba74\uc5d0\uc11c \uc8fc\ubaa9\uc744 \ubc1b\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uccab\uc9f8, \uce58\ub9e4 \uc57d \uc911\uc5d0\uc11c \ucd5c\ucd08\ub85c Disease modifying drug\ub77c\ub294 \ud0c0\uc774\ud2c0\uc774 \ubd99\uc740 \uc57d\uc785\ub2c8\ub2e4. \uae30\uc874\uc758 \uc57d\ub4e4\uc740 \uc99d\uc0c1\uc758 \ucd9c\ud604\uc744 \uc57d\uac04 \ub2a6\ucd94\uc5c8\uc9c0 \ubcd1\uc774 \uc9c4\ud589\ud558\ub294 \uac83\uc744 \ub9c9\uc9c0 \ubabb\ud588\uc73c\ub098, \uc544\ub450\uce74\ub204\ub9d9\uc740 \ubcd1\uc758 \uc9c4\ud589 \uae30\uc804 \uc790\uccb4\ub97c \ub2a6\ucd9c \uc218 \uc788\ub2e4\ub294 \uc810\uc5d0\uc11c \uc644\uc804\ud788 \ucc28\ubcc4\ud654\ub418\uae30\uc5d0 \ub9ce\uc740 \uae30\ub300\ub97c \ubc1b\uc544\uc654\uc2b5\ub2c8\ub2e4. \ud55c\ud3b8\uc73c\ub85c, \uc790\ubb38\uc704\uc6d0\ud68c(Peripheral and Central Nervous System Drugs Advisory Committee) \uc804\uc6d0\uc774 FDA\uc5d0 \uc2b9\uc778 \ubc18\ub300 \uc758\uc0ac\ub97c \ud45c\uba85\ud588\uc74c\uc5d0\ub3c4 \ubd88\uad6c\ud558\uace0 \uc2b9\uc778\ub41c \uc57d\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n

https:\/\/brunch.co.kr\/@gn20sep\/25
<\/a><\/p>\n\n\n\n

\uc544\ub450\uce74\ub204\ub9d9\uc740 \uc54c\uce20\ud558\uc774\uba38 \ubcd1\uc744 \uac00\uc9c4 \uacbd\ub3c4\uc778\uc9c0\uc7a5\uc560 \ud658\uc790\uc640 \uc54c\uce20\ud558\uc774\uba38 \uce58\ub9e4 \ucd08\uae30 \ud658\uc790\ub97c \ub300\uc0c1\uc73c\ub85c \ud558\ub294\ub370, \uce58\ub9e4\uac00 \uc5c6\ub294 \uac74\uac15\ud55c \uace0\ub839 \ud658\uc790\uc5d0\uc11c \ubca0\ud0c0 \uc544\ubc00\ub85c\uc774\ub4dc \ud50c\ub77c\ud06c(beta amyloid plaque)\uc5d0 \ub300\ud56d\ud558\uc5ec \uc2f8\uc6b0\ub294 \ud56d\uccb4\ub97c \ub9cc\ub4e4 \uc218 \uc788\ub294 \uba74\uc5ed \uc138\ud3ec\ub97c \ucc3e\uc740 \uac83\uc774 \uc57d\ubb3c \uac1c\ubc1c\uc758 \uc2dc\uc791\uc774\uc5c8\uc2b5\ub2c8\ub2e4. \uc9c0\uae08\uae4c\uc9c0 \uc544\ubc00\ub85c\uc774\ub4dc \ubca0\ud0c0 \ud50c\ub77c\ud06c \ub2e8\ubc31\uc9c8\uc774 \uc54c\uce20\ud558\uc774\uba38 \uce58\ub9e4\ub97c \uc720\ubc1c\ud558\ub294 \uc808\ub300\uc801\uc778 \uc6d0\uc778 \uc778\uc790\ub77c\ub294 ‘\uc544\ubc00\ub85c\uc774\ub4dc \uac00\uc124’\uc774 \uc9c0\ubc30\uc801\uc774\uc5c8\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n

\uc54c\uce20\ud558\uc774\uba38 \uce58\ub9e4 \uce58\ub8cc\uac00 \uc5b4\ub824\uc6b4 \uae4c\ub2ed<\/strong><\/p>\n\n\n\n

  1. \uc99d\uc0c1\uc774 \ub098\ud0c0\ub098\uae30 20\ub144 \uc804\ubd80\ud130 \ubcd1\ub9ac \uae30\uc804\uc774 \uc2dc\uc791\ub41c\ub2e4.
    \uc784\uc0c1\uc801\uc73c\ub85c \uc774 \uc0ac\ub78c\uc774 ‘\ud658\uc790\uac00 \ub420\uc9c0 \uc548 \ub420\uc9c0 \ud310\ub2e8\ub3c4 \uc548 \ub418\ub294’ \uba3c \uacfc\uac70 \uc2dc\uc810\uc5d0 \uc774\ubbf8 \ubcd1\uc774 \uc2dc\uc791\ub429\ub2c8\ub2e4. \ub1cc\uc5d0 \ub3c5\uc131 \uc544\ubc00\ub85c\uc774\ub4dc \ubca0\ud0c0 \ud50c\ub77c\ud06c \ub2e8\ubc31\uc9c8 \ub369\uc5b4\ub9ac\uac00 \ucd95\uc801\ub418\uae30 \uc2dc\uc791\ud569\ub2c8\ub2e4. \uc544\ubc00\ub85c\uc774\ub4dc\uac00 \ud654\ud559\uc801\uc778 \ubcc0\uc131 \uacfc\uc815\uc744 \uac70\uce58\uba70 \ud50c\ub77c\ud06c \ub369\uc5b4\ub9ac\ub85c \ubb49\uccd0\uc9c0\uace0 \uc313\uc774\ub294 \uacfc\uc815\uc744 \ud754\ud788\ub4e4 \uacc4\ub2e8\uc2dd \ud3ed\ud3ec(cascade)\uc5d0 \ube44\uc720\ud569\ub2c8\ub2e4. \uac70\ub300\ud55c \ud3ed\ud3ec\uc218\uc758 \ud750\ub984(\ucd5c\uc885 \ud0c0\uc6b0 \ud50c\ub77c\ud06c \ub2e8\ubc31\uc9c8, tau plaque)\uc744 \ub9c9\uace0 \uc2f6\ub2e4\uba74 \uacc4\ub2e8\uc758 \uaf2d\ub300\uae30 \uc2dc\uc791\uc810\uc5d0\uc11c \ubb3c(\uc544\ubc00\ub85c\uc774\ub4dc \ubca0\ud0c0 \ub2e8\ubc31\uc9c8, amyloid beta)\uc774 \ub5a8\uc5b4\uc9c0\ub294 \uac83\ubd80\ud130 \ub9c9\uc544\uc57c\uaca0\uc8e0? \uadf8 \uc2dc\uc810\uc744 \ub193\uce58\uba74 \ub4a4\ub2a6\uac8c \ud2c0\uc5b4\ub9c9\uc544\ub3c4 \uc18c\uc6a9\uc774 \uc5c6\uc2b5\ub2c8\ub2e4. \uadf8\ub807\ub2e4\uba74 \uce58\ub9e4 \uc99d\uc0c1\uc774 \ubc1c\ud604\ub418\uae30 \ud55c\ucc38 \uc774\uc804\ubd80\ud130 \uc774 \uc8fc\uc0ac\ub97c \ud22c\uc5ec\ud574\uc57c \ud558\ub294 \uac83\uc774 \ub51c\ub808\ub9c8\uc785\ub2c8\ub2e4. \uc2dc\uc791\ud558\uba74 \ud3c9\uc0dd \ub9e4\ub2ec \ud22c\uc5ec\ud574\uc57c \ud569\ub2c8\ub2e4. \ud558\uc9c0\ub9cc \uadf8\uac8c \uc27d\uc9c0 \uc54a\uaca0\uc8e0. \ub610\ud55c \uadf8 \uc2dc\uc810\uc744 \uc5b4\ub5bb\uac8c \uc54c \uc218 \uc788\ub290\ub0d0\ub3c4 \ubb38\uc81c\uc785\ub2c8\ub2e4. \uadf8\ub798\uc11c 3\uc0c1 \uc784\uc0c1\uc5d0\uc11c\ub294 \uacbd\ub3c4 \uc778\uc9c0 \uc7a5\uc560\uc640 \ucd08\uae30 \uc54c\uce20\ud558\uc774\uba38 \uce58\ub9e4\ub85c \ud655\uc9c4\ub41c \ud658\uc790\ub4e4\uc744 \ub300\uc0c1\uc73c\ub85c \ud558\uc600\uace0, \ubc14\uc774\uc624\ub9c8\ucee4 \ud655\uc778\uc744 \uc704\ud574 \ub1cc\ucc99\uc218\uc561 \uac80\uc0ac\uc640 \ud575\uc758\ud559 \uc601\uc0c1 \uac80\uc0ac(amyloid PET, tau PET)\ub97c \ud558\uc600\uc2b5\ub2c8\ub2e4.<\/li>
  2. \uacfc\uc5f0 \uce58\ub9e4\uc758 \uc6d0\uc778\uc774 ‘\uc815\ub9d0\ub85c’ \uc544\ubc00\ub85c\uc774\ub4dc\uc77c\uae4c? – \uc544\ubc00\ub85c\uc774\ub4dc \uac00\uc124\uc5d0 \ub300\ud55c \ubc18\ubc1c
    \uc774\uac74 \uc880 \ub354 \uadfc\ubcf8\uc801\uc778 \ubb38\uc81c\uc785\ub2c8\ub2e4. 20\ub144 \uac00\uae4c\uc774 \uc218\ub9ce\uc740 \uac1c\ubc1c\uc0ac\ub4e4\uc774 \uc544\ubc00\ub85c\uc774\ub4dc\uc5d0 \uae30\ubc18\ud558\uc5ec \uce58\ub8cc\uc81c \uac1c\ubc1c\uc5d0 \ub9e4\ub2ec\ub838\ub294\ub370, \uadf8 \uc2dc\uc791\ubd80\ud130 \ubb38\uc81c\ub77c\uba74? \uc54c\uce20\ud558\uc774\uba38 \uc6d0\uc778\uc774 \uc544\ubc00\ub85c\uc774\ub4dc\uac00 \uc544\ub2cc \ub2e4\ub978 \uac83\uc5d0 \uc788\ub2e4\ub294 \uac00\uc124\uacfc \uadfc\uac70\uac00 \ud798\uc744 \uc5bb\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/li><\/ol>\n\n\n\n

    2020\ub144 11\uc6d4, \uc54c\uce20\ud558\uc774\uba38 \ubcd1\ub9ac \uae30\uc804\uc758 \uc8fc\uc778\uacf5\uc774 \ubc14\ub00c\ub294 \ud68d\uae30\uc801\uc778 \uc5f0\uad6c \uacb0\uacfc\uac00 \uad6d\ub0b4 \uc5f0\uad6c\uc9c4\uc5d0 \uc758\ud574 Nature Neuroscience\uc5d0 \ubc1c\ud45c\ub418\uc5c8\uc2b5\ub2c8\ub2e4. \uc774 \uc5f0\uad6c\ub294 \ubcc4\uc138\ud3ec(astrocyte, microglial cell)\uc5d0 \uc8fc\ubaa9\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \ubcc4\uc138\ud3ec\ub294 \uc2e0\uacbd\uc138\ud3ec\uac00 \uc544\ub2c8\uace0, \uc2e0\uacbd\uc138\ud3ec\uc758 \ud658\uacbd\uc744 \uc870\uc808\ud569\ub2c8\ub2e4. \ubcc4\uc138\ud3ec\ub294 \uc6d0\ub798 \uc2a4\ud2b8\ub808\uc2a4\uc5d0 \uc800\ud56d\ub825\uc774 \ud06c\uace0 \uc190\uc0c1\uc744 \uc785\uc5b4\ub3c4 \ud68c\ubcf5\uc774 \uc798 \ub418\uc5c8\ub294\ub370, \ub9cc\uc131\uc801\uc778 \uc2a4\ud2b8\ub808\uc2a4\ub85c \uc190\uc0c1\uc774 \uc911\ucca9\ub418\uba74 \ud68c\ubcf5\uc774 \uc798 \ub418\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4. \uc2e0\uacbd\uc138\ud3ec\uc758 \ud658\uacbd\uc744 \uc870\uc808\ud574\uc8fc\ub294 \ud50c\ub808\uc774\uc5b4(\uccad\uc18c\ubd80)\uac00 \uc544\ud504\uba74, \uadf8 \ud50c\ub808\uc774\uc5b4\ub85c\ubd80\ud130 \ubcf4\ud638\ub97c \ubc1b\ub294 \uc2e0\uacbd\uc138\ud3ec\ub3c4 \uc190\uc0c1\uc774 \ub418\uaca0\uc8e0. \uc548 \uadf8\ub798\ub3c4 \uc2a4\ud2b8\ub808\uc2a4\uc5d0 \uc608\ubbfc\ud55c \uc2e0\uacbd\uc138\ud3ec\uac00 \ub354 \uc798 \uc544\ud504\uac8c \ub429\ub2c8\ub2e4.<\/p>\n\n\n\n

    \uccad\uc18c\ubd80\uc778 \ubcc4\uc138\ud3ec\uac00 \uace8\uace8 \ub300\uba74 \ub178\ud3d0\ubb3c\uc774\uc5c8\ub358 \uc544\ubc00\ub85c\uc774\ub4dc\uac00 \uc2e0\uacbd \uc138\ud3ec \uc0ac\uc774\uc0ac\uc774\uc5d0 \uac00\ub4dd\ud574\uc9d1\ub2c8\ub2e4. \uadf8\ub7fc \uc2e0\uacbd \uc138\ud3ec\ub4e4 \uc0ac\uc774\uc758 \ucee4\ubba4\ub2c8\ucf00\uc774\uc158\uc774 \ubc29\ud574\ub97c \ubc1b\uc2b5\ub2c8\ub2e4. \uc544\ubc00\ub85c\uc774\ub4dc\ub294 \ub3c5\uc131\uc744 \uac00\uc9c0\uae30\uc5d0 \uba74\uc5ed \ubc18\uc751\uc774 \uc2dc\uc791\ub418\uace0, \uc774 \uc5fc\uc99d \uacfc\uc815\uc73c\ub85c \uc2e0\uacbd \uc138\ud3ec\uac00 \ub354 \uc190\uc0c1\uc774 \ub429\ub2c8\ub2e4. \ubcc4\uc138\ud3ec\ub294 \ubcf8\uc778 \ub2a5\ub825\uc758 \ud55c\uacc4\uce58\uc5d0 \ub2e4\ub2e4\ub974\uace0 \uacfc\ub3c4\ud55c \ud65c\uc131\ud654\ub85c \uc911\uc99d \ubc18\uc751\uc131 \ubcc4\uc138\ud3ec(severe reactive astrocyte)\uac00 \ub9cc\ub4e4\uc5b4\uc9d1\ub2c8\ub2e4.<\/p>\n\n\n\n

    \ubcc4\uc138\ud3ec\ub294 \uc544\ubc00\ub85c\uc774\ub4dc\ub97c \ubd84\ud574\ud558\uae30 \uc704\ud55c \ub3c4\uad6c\ub85c \ud6a8\uc18c(\ubaa8\ub178\uc544\ubbfc \uc0b0\ud654\ud6a8\uc18c B, MAO-B)\ub97c \ud65c\uc131\ud654\uc2dc\ud0a4\ub294\ub370, \uc774 \uacfc\uc815\uc5d0\uc11c \uacfc\ub3c4\ud558\uac8c \uc0dd\uc131\ub41c \uacfc\uc0b0\ud654\uc218\uc18c\uac00 \uc911\uc99d \ubc18\uc751\uc131 \ubcc4\uc138\ud3ec\ub97c \ub9cc\ub4e4\uc5b4\ub0c5\ub2c8\ub2e4. \uc720\ub3c4\ub41c \uc911\uc99d \ubc18\uc751\uc131 \ubcc4\uc138\ud3ec\ub294 \uc2e0\uacbd \uc138\ud3ec\ub97c \ub354\uc6b1 \uc190\uc0c1\uc2dc\ud0a4\uace0, \uc544\ubc00\ub85c\uc774\ub4dc\uac00 \ub354\uc6b1 \ucd95\uc801\ub418\ub294 \uac83\uc774\uc8e0. \uc544\ubc00\ub85c\uc774\ub4dc\ub97c \uc544\ubb34\ub9ac \uc81c\uac70\ud574\uc918\ub3c4 \uc77c\ub2e8 \uc911\uc99d \ubc18\uc751\uc131 \ubcc4\uc138\ud3ec\uac00 \uc720\ub3c4\ub418\uba74 \ube44\uac00\uc5ed\uc801\uc73c\ub85c \uce58\ub9e4\uac00 \uc9c4\ud589\ub420 \uac83\uc785\ub2c8\ub2e4. \uadf8\ub798\uc11c \ub2e8\uc21c\ud788 \uc544\ubc00\ub85c\uc774\ub4dc\ub9cc\uc744 \ud0c0\uac9f\ud305\ud574\uc11c \uce58\ub8cc\uc81c\ub97c \uac1c\ubc1c\ud558\ub294 \uac83\uc774 \ub3c4\uc6c0\uc774 \ub418\uc9c0 \uc54a\uc744 \uac83\uc774\ub77c\ub294 \uc804\ubb38\uac00\ub4e4\uc758 \uc758\uacac\uc774 \ub098\uc624\ub294 \uac83\uc774\uc8e0. \ub530\ub77c\uc11c \uc911\uc99d \ubc18\uc751\uc131 \ubcc4\uc138\ud3ec\uac00 \uc0dd\uc131\ub418\ub294 \uacfc\uc815\uc744 \ubaa9\ud45c\ub85c \ud558\ub294 \uce58\ub8cc\uc81c\uc758 \uac1c\ub150\uc774 \ud798\uc744 \uc5bb\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n

    \ub2e4\uc2dc \ud55c\ubc88 \uac15\uc870\ud558\uc9c0\ub9cc, \uc544\ubc00\ub85c\uc774\ub4dc\ub294 \uc54c\uce20\ud558\uc774\uba38 \ubcd1\uc778\uc758 \uc5ec\uc804\ud788 \uc911\uc694\ud55c \uc778\uc790\uc774\uace0, \uc138\ud3ec \ubd80\uc0b0\ubb3c \ub4f1\uc758 \uc4f0\ub808\uae30\ub4e4\uc744 \uce58\uc6cc\uc11c \ud658\uacbd\uc744 \uc815\ud654\uc2dc\ud0a4\ub294 \ubcc4\uc138\ud3ec(astrocyte, microglial cell)\uc758 \uae30\ub2a5\uc774 \uae09\ubd80\uc0c1\ub418\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uce58\ub9e4\uac00 \uc2dc\uc791\ub418\uae30 \uc804\uc5d0 \ubcc4\uc138\ud3ec\uac00 \uc870\uae30\uc5d0 \uc544\ubc00\ub85c\uc774\ub4dc \ud50c\ub77c\ud06c \ub2e8\ubc31\uc9c8\uc744 \ucc98\ub9ac\ud560 \uc218 \uc788\uc73c\uba74 \uc774\uc0c1\uc801\uc774\uaca0\uc9c0\uc694. \uc544\ub450\uce74\ub204\ub9d9\uc740 \uc774\ub7f0 \uba74\uc5ed \ubc18\uc751\uc744 \uc720\ubc1c\ud558\uc5ec Microglial cell\uc774 \uc801\uc808\ud558\uac8c \uc544\ubc00\ub85c\uc774\ub4dc\ub97c \uac10\uc9c0\ud558\uc5ec \ucc98\ub9ac\ud560 \uc218 \uc788\uac8c \ud574 \uc904 \uac83\uc774\ub77c\uace0 \uc0dd\uac01\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n

    \uc544\ub450\uce74\ub204\ub9d9\uc758 \uc784\uc0c1 3\uc0c1 \uacb0\uacfc\uc5d0 \ub530\ub974\uba74, \uace0\uc6a9\ub7c9\uc744 \ud22c\uc5ec\ud560\uc218\ub85d \ub354 \ud6a8\uacfc\uc801\uc73c\ub85c \ubcd1\uc778\uc744 \uc81c\uac70\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \ud558\uc9c0\ub9cc \uc544\ub450\uce74\ub204\ub9d9 \uace0\uc6a9\ub7c9\uc740 \ud2b9\uc815 \uc720\uc804\uc790 \uadf8\ub8f9\uc5d0\uc11c \ub1cc\ubd80\uc885\uc744 \uc720\ubc1c\ud560 \uc218 \uc788\uc5b4 \uce58\uba85\uc801\uc77c \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uadf8\ub7f0\ub370 \ub1cc\ubd80\uc885\uc774 \uc798 \uc0dd\uae30\ub294 \uc720\uc804\uc790 APOE4\uc5d0\uc11c \uc57d\uc758 \ud6a8\ub2a5\uc774 \ub354 \uc88b\ub2e4\ub294 \ubaa8\uc21c\ub3c4 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n

    \ub9cc\uc57d\uc5d0 \uc544\ub450\uce74\ub204\ub9d9 \uc2dc\ud310 \ud6c4\uc758 \ub370\uc774\ud130\uc5d0 \ub530\ub77c \uc57d \uc790\uccb4\uc758 \uc5ed\ud560\uc5d0 \ub300\ud55c \ubbff\uc74c\uc774 \uacac\uace0\ud574\uc9c4\ub2e4\uba74, \ub0a8\uc740 \ubb38\uc81c\ub294 \uc9c8\ubcd1\uc774 \uc2dc\uc791\ub418\uae30 \uc804\uc5d0 \uc870\uae30\uc5d0 \uc870\uc9d0\uc744 \ucc3e\uc544\ub0b4\uc5b4 \ud22c\uc5ec\ub97c \uc2dc\uc791\ud560 \uc218 \uc788\ub290\ub0d0 \uc785\ub2c8\ub2e4. \uadf8\ub798\uc11c \uce58\ub8cc\uc81c \uc5f0\uad6c\uc758 \ub2e4\ub978 \ud55c \ucd95\uc5d0\ub294 \uc870\uae30 \ubc1c\uacac \ubc14\uc774\uc624\ub9c8\ucee4(biomarker) \uac1c\ubc1c\uc774 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n

    \ubbf8\uad6d FDA\uc758 \uace0\ubbfc\uacfc \ub17c\ub9ac
    <\/strong>\uc0ac\uc2e4 \uc544\ub450\uce74\ub204\ub9d9\uc740 3\uc0c1 \uc784\uc0c1\uc5d0\uc11c 1\ucc28 \uc9c0\ud45c(primary endpoint)\uc640 2\ucc28 \uc9c0\ud45c \ubaa8\ub450 \uc720\uc758\ubbf8\ud55c \ud6a8\ub2a5\uc744 \ubcf4\uc5ec\uc8fc\uc9c0 \ubabb\ud588\uc2b5\ub2c8\ub2e4. \uc27d\uac8c \ub9d0\ud558\uba74 \uc544\uc9c1 \uc544\ub450\uce74\ub204\ub9d9\uc774 \uc784\uc0c1\uc801\uc73c\ub85c \ud658\uc790\uc5d0\uac8c \uc774\ub4dd\uc744 \uc904 \uac70\ub77c\ub294 \uc720\uc758\ubbf8\ud55c \ud1b5\uacc4\uc801 \uc99d\uac70\ub294 \ubd80\uc871\ud569\ub2c8\ub2e4. \uadf8\ub798\uc11c \uc790\ubb38\uc704\uc6d0\ud68c\uc5d0\uc11c \uc804\uc6d0 \uc2b9\uc778 \ubc18\ub300\ub97c \ud588\uc2b5\ub2c8\ub2e4. \ud558\uc9c0\ub9cc \ubb34\uc2dc\ud560 \uc218 \uc5c6\ub294 \ud558\uc704 \ubd84\uc11d \uacb0\uacfc\uac00 \ubc84\ud2f0\uace0 \uc788\uc5c8\uc2b5\ub2c8\ub2e4. \ub610\ud55c \uacb0\uc815\uc801\uc73c\ub85c, \ud658\uc790 \ubcf4\ud638\uc790\ub4e4\uacfc \uc9c4\ub8cc \ud604\uc7a5\uc758 \uae30\ub300\uac00 \ub108\ubb34\ub098 \ucef8\ub358 \uc57d\uc785\ub2c8\ub2e4. \uc2e0\uacbd\uacfc \uc758\uc0ac \uc785\uc7a5\uc5d0\uc11c\ub3c4 (\ud1b5\uacc4\uc801 \uc720\uc758\uc131\uc744 \ub5a0\ub098) \uc6cc\ub099 \uce58\ub9e4 \ud658\uc790\ub4e4\uc5d0\uac8c \uc4f8 \uc218 \uc788\ub294 \uc57d\uacfc \ub300\uc548\uc774 \uc5c6\ub294 \ub9c8\ub2f9\uc5d0, \uc2b9\uc778\uc774 \ub418\uba74 \uc774 \uc57d\uc744 \uc4f0\uace0 \uc2f6\uc740 \ub9c8\uc74c\uc774 \uc6b0\uc120\uc785\ub2c8\ub2e4. \uae30\ub300\uac00 \uc5b4\ub9c8\uc5b4\ub9c8\ud55c\ub370, \ud1b5\uacc4\uc801 \uc801\ud569\uc131\ub9cc \uac00\uc9c0\uace0 \ucca0\ud1f4\ub97c \ub193\uae30 \ub108\ubb34 \uc5b4\ub824\uc6b4 \uc0c1\ud669\uc774\uc5c8\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n

    FDA\uac00 \uc2b9\uc778\uc744 \ud55c \uae30\uc900\uc740 \ub300\ub9ac \ud45c\uc9c0\uc790(surrogate endpoint)\uc778 \uc544\ubc00\ub85c\uc774\ub4dc \ud50c\ub77c\ud06c\uc785\ub2c8\ub2e4. \uc544\ub450\uce74\ub204\ub9d9\uc758 \uc6a9\ub7c9\uacfc \ubcf5\uc6a9 \uae30\uac04\uc5d0 \ube44\ub840\ud558\uc5ec \uc544\ubc00\ub85c\uc774\ub4dc\uac00 \uac10\uc18c\ud55c\ub2e4\ub294 \uac83\uc774 \uc77c\uad00\ub418\uac8c \ud655\uc778\ub41c\ub2e4\uace0 \ud310\ub2e8\uc758 \uadfc\uac70\ub97c \uba85\uc2dc\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uc544\ubc00\ub85c\uc774\ub4dc \ud50c\ub77c\ud06c\uac00 \uac10\uc18c\ud55c\ub2e4\uba74 \uacb0\uad6d \uc784\uc0c1\uc801\uc73c\ub85c\ub3c4 \uc778\uc9c0 \uae30\ub2a5\uc758 \uac10\ud1f4\ub97c \ub2a6\ucd9c \uac83\uc774\ub77c\uace0 \uc608\uc0c1\ud558\ub294 \uac83\uc774 \uadf8\ub4e4\uc758 \ub17c\ub9ac\uc785\ub2c8\ub2e4. \ub9d0 \uadf8\ub300\ub85c \uc544\ubc00\ub85c\uc774\ub4dc \ud45c\uc9c0\uc790\uac00 \uc784\uc0c1 \uc99d\uc0c1 \uc9c0\ud45c\ub97c ‘\ub300\ub9ac’\ud558\uc5ec \ud310\ub2e8\uc758 \uae30\uc900\uc73c\ub85c \uc0bc\uc558\uc2b5\ub2c8\ub2e4. \uc9c0\uae08\uae4c\uc9c0 \uc81c\uc655\uc758 \uc790\ub9ac\uc5d0 \uc788\ub294 \uc544\ubc00\ub85c\uc774\ub4dc \uac00\uc124\uc744 \uc5ec\uc804\ud788 \uc9c0\uc9c0\ud558\uba74\uc11c\ub3c4(\ubcf4\uc218\uc801 \ub17c\ub9ac), \ubc29\ubc95\ub860\uc801\uc73c\ub85c\ub294 \ud601\uc2e0\uc801\uc778 \uae38\uc744 \ud0dd\ud558\uc600\uc2b5\ub2c8\ub2e4. \uc804\ud1b5\uc801\uc778 \uc2b9\uc778 \uae30\uc900\uc740 \ub300\ub9ac \ud45c\uc9c0\uc790\uac00 \uc544\ub2cc, 1,2\ucc28 \uc9c0\ud45c\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n

    FDA\uc758 \uac00\uc18d \uc2b9\uc778 \uacfc\uc815(Accelerated Approval pathway)
    \uc6cc\ub099 \uc54c\uce20\ud558\uc774\uba38 \uce58\ub9e4\uac00 \uc9c0\ub09c\ud558\uace0 \uace0\ud1b5\uc2a4\ub7ec\uc6b4 \uc9c8\ubcd1\uc774\uba70, 20\ub144 \uac00\uae4c\uc774 \uc2e0\uc57d\uc774 \uc2e4\ud328\ud55c \uac83\uc5d0 \ub300\ud55c \ud658\uc790\ub4e4\uc758 \ubbf8\ucda9\uc871 \uc218\uc694(unmet medical need)\uac00 \uc808\uc2e4\ud55c \ubc30\uacbd\uc5d0 \ubc29\uc810\uc744 \ub450\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uadf8\ub9ac\ud558\uc5ec \ub9ac\uc2a4\ud06c\ubcf4\ub2e4\ub294 \uc774\ub4dd\uc774 \uc120\ud68c\ud55c\ub2e4\uace0 \ud310\ub2e8\uc744 \ud558\uc5ec \uac00\uc18d \uc2b9\uc778 \uc808\ucc28\ub97c \ubc1f\uc558\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n

    \ubbf8\uad6d \ub514\uc9c0\ud138 \ud5ec\uc2a4\ucf00\uc5b4 \ubd84\uc57c\uc758 \ub2e4\uc591\ud55c \ub514\uc9c0\ud138 \uce58\ub8cc\uc81c\uc640 \uc6d0\uaca9 \uc758\ub8cc \uc2dc\uc7a5\uc774 \ucee4\uc9c0\uba74\uc11c, FDA\ub294 \ud601\uc2e0\uc801\uc778 \uc2ec\uc0ac\uae30\uc900\uc744 \ub0b4\ub193\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uaddc\uc81c \uae30\uad00\uc774 \uc5c5\uacc4\ubcf4\ub2e4 \ub354 \ud601\uc2e0\uc801\uc774\ub77c\uace0 \uc2e4\ub9ac\ucf58\ubca8\ub9ac\uc5d0\uc11c \ud600\ub97c \ub0b4\ub450\ub97c \uc815\ub3c4\uc774\uc9c0\uc694. \uc774\ub7f0 \ub9e5\ub77d\uc758 \uc5f0\uc7a5\uc120\uc778 \uac83 \uac19\uc2b5\ub2c8\ub2e4. \ud1b5\uacc4\uc801\uc778 \ub300\uc6d0\uce59\uc744 \uc5ce\ub294 \uac8c \ud601\uc2e0\uc774\ub0d0\uace0 \ube44\ud310\ud558\ub294 \uc804\ubb38\uac00\ub3c4 \uc788\uc744 \uc218 \uc788\uaca0\uace0, \uac08\uc218\ub85d \uc2e0\uc57d \uac1c\ubc1c \uacfc\uc815\uc5d0 \ub4dc\ub294 \uc5b4\ub9c8\uc5b4\ub9c8\ud55c \ud22c\uc790 \ube44\uc6a9\uacfc \uc2dc\uac04\uc744 \uac10\uc548\ud558\uc5ec \uc2dc\ub300\uc5d0 \ubd80\uc751\ud558\ub294 \uc0c8\ub85c\uc6b4 \uaddc\uc81c \ubc29\uc2dd\uc758 \ud544\uc694\uc131\uc5d0 \ucc2c\uc131\ud558\ub294 \uadf8\ub8f9\ub3c4 \uc788\uaca0\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n

    \uc0b0 \ub118\uc5b4 \uc0b0, \ub0a8\uc740 \ubb38\uc81c\ub4e4
    <\/strong>FDA\ub294 \ud601\uc2e0\uc758 \uc544\uc774\ucf58\uc73c\ub85c \uc0c8\ub85c\uc6b4 \uaddc\uc81c \uae30\uad00\uc758 \ubaa8\uc2b5\uc744 \uc778\uc0c1\uc801\uc73c\ub85c \ub0a8\uacbc\uc9c0\ub9cc, \uc911\uc694\ud55c \uc120\ub840\ub97c \ub0a8\uacbc\uc2b5\ub2c8\ub2e4. \uc784\uc0c1 3\uc0c1\uc5d0\uc11c 1,2\ucc28 \uc9c0\ud45c\uac00 \uc544\ub2cc, 3\uc0c1 \ud558\uc704\ubd84\uc11d \uacb0\uacfc\uc640 2\uc0c1 \uacb0\uacfc\ub9cc\uc744 \uac00\uc9c0\uace0 \uc2b9\uc778\uc744 \ud558\uc600\uae30\uc5d0 \uad00\ub828 \uc5c5\uacc4\uac00 \uc774\ub97c \uacc4\uc18d \ubd99\uc7a1\uace0 \ub298\uc5b4\uc9c8 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \ub610\ud55c \uc704\uc5d0\uc11c \uc124\uba85\ub4dc\ub838\ub4ef\uc774, \uc544\ubc00\ub85c\uc774\ub4dc \uac00\uc124\ub9cc\uc774 \uc720\uc77c\ud55c \ubcd1\uc778\uc774 \uc544\ub2d0 \uc218\ub3c4 \uc788\ub294\ub370 \uac1c\ubc1c\uc790\ub4e4\uc774 \uac70\uae30\uc5d0 \uacc4\uc18d \ub9e4\ub2ec\ub9b4 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n

    \uc2dc\ud310 \uc774\ud6c4\uc758 \uc0c1\ud669\uc5d0 \ubaa8\ub450\uac00 \uc8fc\ubaa9\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uc784\uc0c1\uc801\uc73c\ub85c \uc774\ub4dd\uc774 \uc788\uc744 \uac83\uc778\uc9c0, \ud658\uc790\uc758 \uc608\ud6c4\uac00 \uc5b4\ub5a8 \uac83\uc778\uc9c0 \uc99d\uba85\ud574\ub0b4\uc57c \ud558\ub294 \ucc45\uc784\uc774 \uc788\uc2b5\ub2c8\ub2e4. \uac1c\ubc1c\uc0ac\ub294 4\uc0c1 \uc784\uc0c1(post marketing surveillence, PMS)\uc758 \uacb0\uacfc\ub97c \ud1b5\ud574 \ub2e4\uc2dc \ucee8\ud38c\uc744 \ubc1b\uc544\uc57c \ud558\uace0, \ub9cc\uc57d 4\uc0c1\uc5d0\uc11c \ud6a8\ub2a5\uc744 \uc99d\uba85\ud558\uc9c0 \ubabb\ud55c\ub2e4\uba74 \uc2dc\uc7a5\uc5d0\uc11c \ucca0\uc218\ud574\uc57c \ud569\ub2c8\ub2e4. \uc774 \ubaa8\ub4e0 \uacfc\uc815\uc744 \uc9c0\ucf1c\ubcf4\ub294 FDA\uc758 \ub9c8\uc74c\uc740 \ubb34\uac81\uace0 \ucc45\uc784\uac10\uc774 \ud074 \uac83\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n

    \uac00\uc131\ube44\ub3c4 \ud070 \ubb38\uc81c\uc785\ub2c8\ub2e4. \ub9e4\ub2ec 1\ud68c\uc529 \ud3c9\uc0dd \uc8fc\uc0ac\ub97c \ub9de\uc544\uc57c \ud558\ub294 \ubd80\ub2f4\uac10, 1\ud68c \uc8fc\uc0ac \uac00\uaca9(4312\ub2ec\ub7ec)\uc744 \uac10\uc548\ud558\uba74 1\ub144 \ube44\uc6a9\uc774 \uc218\ucc9c\ub9cc \uc6d0\uc778\ub370 \ub204\uac00 \uac10\ub2f9\ud560 \uc218 \uc788\uc744\uc9c0, \ud5c8\uac00 \uc870\uac74\uc73c\ub85c \ub1cc\ubd80\uc885 \ud655\uc778\uc744 \uc704\ud558\uc5ec \uc790\uc8fc MR\uc744 \ucd94\uc801 \ud655\uc778\ud574\uc57c \ud55c\ub2e4\ub294 \ube44\ud604\uc2e4\uc131 \ub4f1 \uc0b0\uc801\ud55c \ubb38\uc81c\uac00 \ub9ce\uc2b5\ub2c8\ub2e4. \uadf8\ub798\ub3c4 \uc815\ub9d0 \uc624\ub79c\ub9cc\uc5d0 \ube5b\uc744 \ubcf4\ub294 \uce58\ub9e4 \uc2e0\uc57d\uc5d0 \ub300\ud55c \uc560\uc815 \uc788\ub294 \uc8fc\uc2dc\uac00 \ud544\uc694\ud560 \uac83\uc73c\ub85c \uc0dd\uac01\ub429\ub2c8\ub2e4.<\/p>\n\n\n\n

    <\ucc38\uace0 \ubb38\ud5cc><\/p>\n\n\n\n

    1. https:\/\/www.dzne.de\/en\/<\/a><\/li>
    2. https:\/\/www.zora.uzh.ch\/id\/eprint\/130301\/<\/a><\/li>
    3. https:\/\/www.nature.com\/articles\/nature19323<\/a><\/li>
    4. https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02484547<\/a><\/li>
    5. https:\/\/alz-journals.onlinelibrary.wiley.com\/doi\/10.1002\/alz.12213<\/a><\/li>
    6. http:\/\/www.biospectator.com\/view\/news_view.php?varAtcId=11801<\/a><\/li>
    7. https:\/\/www.fda.gov\/drugs\/news-events-human-drugs\/fdas-decision-approve-new-treatment-alzheimers-disease<\/a><\/li><\/ol>\n\n\n\n
      <\/div>\n\n\n\n