{"id":146466,"date":"2022-09-02T01:33:59","date_gmt":"2022-09-02T01:33:59","guid":{"rendered":"https:\/\/labinsights.com\/acf_article\/%ec%83%88%eb%a1%9c%ec%9a%b4-%ed%98%88%ec%9a%b0%eb%b3%91-%ec%b9%98%eb%a3%8c%eb%b2%95%ec%9d%80-%ed%92%88%ec%a7%88-%ec%a7%84%eb%8b%a8%ec%9d%98-%ed%95%84%ec%9a%94%ec%84%b1%ec%9d%84-%ea%b0%95%ec%a1%b0\/"},"modified":"2026-02-17T05:10:38","modified_gmt":"2026-02-17T05:10:38","slug":"emerging-haemophilia-therapies-highlight-a-need-for-quality-diagnostics","status":"publish","type":"acf_article","link":"https:\/\/labinsights.com\/ko\/disease-area\/rare-diseases\/emerging-haemophilia-therapies-highlight-a-need-for-quality-diagnostics\/","title":{"rendered":"\uc0c8\ub85c\uc6b4 \ud608\uc6b0\ubcd1 \uce58\ub8cc\ubc95\uc740 \ud488\uc9c8 \uc9c4\ub2e8\uc758 \ud544\uc694\uc131\uc744 \uac15\uc870\ud569\ub2c8\ub2e4"},"content":{"rendered":"

\uc774 \uae30\uc0ac\ub294 \ud608\uc6b0\ubcd1 \uc9c4\ub2e8 \ubc0f \uce58\ub8cc\ubc95\uc5d0 \uad00\ud55c \uc2dc\ub9ac\uc988\uc758 \ud30c\ud2b8 2\uc785\ub2c8\ub2e4. \uc5ec\uae30\uc5d0\uc11c<\/a> \ubcfc \uc218\uc788\ub294 \uccab \ubc88\uc9f8 \uae30\uc0ac\ub294 \uc784\uc0c1 \ud45c\ud604, \uc9c4\ub2e8 \ubc0f \uce58\ub8cc\uc5d0 \ub300\ud55c \uac1c\uc694\ub97c \uc81c\uacf5\ud569\ub2c8\ub2e4.<\/p>\n

\uc5f0\uad6c\uc790\ub4e4\uc774 \ud608\uc6b0\ubcd1\uc5d0 \ub300\ud55c \ud601\uc2e0\uc801\uc778 \uc0c8\ub85c\uc6b4 \uce58\ub8cc\ubc95\uc744 \uac1c\ubc1c\ud568\uc5d0 \ub530\ub77c \uc784\uc0c1 \uc2e4\ud5d8\uc2e4 \uc804\ubb38\uac00\ub294 \uc774\ub7ec\ud55c \ubc1c\uc804\uacfc \uc9c4\ub2e8 \uc6cc\ud06c\ud50c\ub85c\uc5d0 \ub300\ud55c \uc7a0\uc7ac\uc801 \uc601\ud5a5\uc744 \uc54c\uace0 \uc788\uc5b4\uc57c \ud569\ub2c8\ub2e4. \uc774 \uae30\uc0ac\uc5d0\uc11c\ub294 \uba87 \uac00\uc9c0 \uc0c8\ub85c\uc6b4 \uce58\ub8cc \uc591\uc2dd\uacfc \uc2e4\ud5d8\uc2e4 \uc758\ud559\uc5d0 \ub300\ud55c \uc758\ubbf8\ub97c \ud0d0\uad6c\ud569\ub2c8\ub2e4.<\/p>\n

\ud608\uc6b0\ubcd1\uc5d0 \ub300\ud55c \uc0c8\ub85c\uc6b4 \uce58\ub8cc\ubc95\uc740 \ubb34\uc5c7\uc785\ub2c8\uae4c?<\/h2>\n

\uc624\ub298\ub0a0 \ud608\uc6b0\ubcd1 \uce58\ub8cc\ub294 \uc751\uace0 \uc778\uc790\ub97c \uc0ac\uc6a9\ud558\uc5ec \ud658\uc790\uc758 \ud608\uc561\uc744 \ubcf4\ucda9\ud558\ub294 \uacfc\uc815\uc778 \ub300\uccb4 \uc694\ubc95\uc5d0 \uc911\uc810\uc744 \ub450\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uc774\ub7ec\ud55c \uce58\ub8cc\ub294 \ud608\uc561 \ub0b4 \uc751\uace0 \uc778\uc790\ub97c \uacf5\uaca9\ud558\ub294 \uc911\ud654 \ud56d\uccb4(\uc5b5\uc81c\uc81c)\uc758 \ubc1c\uc0dd\uacfc \uac19\uc740 \ud569\ubcd1\uc99d\uc744 \uc720\ubc1c\ud558\uace0 \ud608\uc6b0\ubcd1\uc73c\ub85c \uc778\ud55c \uc774\ud658\uc728\uc744 \ub192\uc77c \uc218 \uc788\uc2b5\ub2c8\ub2e4 [1].<\/p>\n

\uc774\ub7ec\ud55c \ubb38\uc81c \ub4f1\uc744 \ud574\uacb0\ud558\uae30 \uc704\ud574 \uc758\ub8cc \uc804\ubb38\uac00\ub4e4\uc740 \ubc18\uac10\uae30 \uc5f0\uc7a5(EHL) \uc751\uace0 \uc778\uc790, \uc870\uc9c1 \uc778\uc790 \uacbd\ub85c \uc5b5\uc81c\uc81c(TFPI)\ub97c \ud45c\uc801\uc73c\ub85c \ud558\ub294 \ub2e8\ud074\ub860 \ud56d\uccb4, \ube44\uc778\uc790 \ub300\uccb4 \uc694\ubc95\uc73c\ub85c \uc791\uc6a9\ud558\ub294 \uc774\uc911\ud2b9\uc774\uc131 \ud56d\uccb4, \uc9c8\ubcd1\uc744 \uce58\ub8cc\ud560 \uac00\ub2a5\uc131\uc774 \uc788\ub294 \uc720\uc804\uc790 \uc694\ubc95 \ub4f1 \ud608\uc6b0\ubcd1 \uce58\ub8cc\uc5d0 \ub300\ud55c \ub2e4\uc591\ud55c \uc0c8\ub85c\uc6b4 \uc811\uadfc\ubc95\uc744 \ubaa8\uc0c9\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n

EHL \uc751\uace0 \uc778\uc790<\/strong><\/p>\n

2010 \ub144\ub300\ubd80\ud130 \uc7ac\uc870\ud569 \uae30\uc220\uc774 \ub3c4\uc785\ub418\uc5b4 \ub354 \uc624\ub798 \uc21c\ud658\ud558\uba70 \ud22c\uc57d \ube48\ub3c4\ub97c \uc904\uc774\ub294 \uc778\uc790\ub97c \uc870\uc791\ud588\uc2b5\ub2c8\ub2e4 [2]. \ud604\uc7ac \u00a0EHL FVIII \ubc0f FXI \uc81c\ud488\uc744 \uc0ac\uc6a9\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \ub2e4\uc591\ud55c EHL \uc81c\ud488\uc758 \uc57d\ub3d9\ud559 \ubc0f \ud6a8\ub2a5\uc740 \ud2b9\ud788 \ucd9c\ud608\uc758 \uc608\ubc29 \ubc0f \uce58\ub8cc\uc5d0\uc11c \uc798 \uc785\uc99d\ub429\ub2c8\ub2e4.<\/p>\n

\uc870\uc9c1\uc778\uc790\uacbd\ub85c \uc5b5\uc81c\uc81c(TFPI)\ub97c \ud45c\uc801\uc73c\ub85c \ud558\ub294 \ub2e8\uc77c\ud074\ub860 \ud56d\uccb4<\/strong><\/p>\n

TFPI \uc5b5\uc81c\uc81c\ub97c \ud45c\uc801\uc73c\ub85c \ud558\ub294 \ub2e8\uc77c\ud074\ub860 \ud56d\uccb4\uc5d0 \ub300\ud55c\uc5ec\ub7ec \uc5f0\uad6c\uac00 \uc9c4\ud589 \uc911\uc774\uba70, \uc774\ub294 \ud5a5\uc0c1\ub41c \uc9c0\ud608 \ud65c\uc131, \ubcf4\ub2e4 \uc548\uc815\uc801\uc778 \ud608\uc804 \ud615\uc131 \ubc0f \ud6c4\uc18d \ucd9c\ud608 \uc0ac\uac74 \uac10\uc18c\ub97c \uae30\ub300\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \ud55c \uac00\uc9c0 \uc608\ub85c \ud608\uc6b0\ubcd1 A \ubc0f B \ud658\uc790\ub97c \ub300\uc0c1\uc73c\ub85c \ud55c \uc784\uc0c1 2\uc0c1 \uc2dc\ud5d8\uc5d0\uc11c \ud3c9\uac00\ub418\uace0 \uc788\ub294 \uc778\uac04 \ub2e8\ud074\ub860 \ud56d\uccb4\uc778 \ucf58\uc2dc\uc8fc\ub9d9\uc774 \uc788\uc2b5\ub2c8\ub2e4.\u00a02023\/4\ub144 EU, \uc601\uad6d \ubc0f \ubbf8\uad6d\uc5d0\uc11c \ud608\uc6b0\ubcd1 A \ub610\ub294 B\uc758 \ucf58\uc2dc\uc8fc\ub9d9\uc5d0 \ub300\ud55c \uaddc\uc81c \uc2b9\uc778\uc774 \uc608\uc0c1\ub429\ub2c8\ub2e4.\u00a0 \ucf58\uc2dc\uc8fc\ub9d9\uacfc \uc720\uc0ac\ud55c \ub610 \ub2e4\ub978 \ub2e8\ud074\ub860 \ud56d\uccb4\uc778 BAY1093884\uc758 1\uc0c1 \uc784\uc0c1 \uc2dc\ud5d8\uc5d0\ub3c4 \ubaa8\uc9d1\uc774 \uc9c4\ud589 \uc911\uc785\ub2c8\ub2e4.<\/p>\n

\ube44\uc778\uc790 \ub300\uccb4 \uc694\ubc95\uc73c\ub85c \uc791\uc6a9\ud558\ub294 \uc774\uc911\ud2b9\uc774\uc131 \ud56d\uccb4<\/strong><\/p>\n

\uae30\ud0c0 \uc0c8\ub85c\uc6b4 \uc694\ubc95\uc5d0\ub294 \ube44\uc778\uc790 \ub300\uccb4 \uc81c\ud488\uc774 \ud3ec\ud568\ub429\ub2c8\ub2e4. \uc774\ub4e4\uc740 \uc77c\ubc18\uc801\uc73c\ub85c \uc751\uace0 \uc778\uc790\ub97c \ubaa8\ubc29\ud558\uc5ec FXIa \ubc0f FX\ub97c \ud6a8\uacfc\uc801\uc73c\ub85c \uc5f0\uacb0\ud558\ub294 \uc5d0\ubbf8\uc2dc\uc8fc\ub9d9\uacfc \uac19\uc740 \uc774\uc911\ud2b9\uc774\uc131 \ud56d\uccb4\uc785\ub2c8\ub2e4. \u00a0\uc5d0\ubbf8\uc2dc\uc8fc\ub9d9\uc740 FVIII \uc5b5\uc81c\uc81c\ub97c \uc0ac\uc6a9\ud558\ub294 \uc131\uc778 \ubc0f \uc18c\uc544 \ud658\uc790\uc758 \uc77c\uc0c1\uc801\uc778 \uc608\ubc29\uc6a9\uc73c\ub85c \uc0ac\uc6a9\ub429\ub2c8\ub2e4. 2018\ub144 4\uc6d4 \ud608\uc6b0\ubcd1 A\uc5d0 \ub300\ud55c \ud68d\uae30\uc801\uc778 \uce58\ub8cc\ubc95\uc73c\ub85c \uc9c0\uc815\ub418\uc2b5\ub2c8\ub2e4[3].<\/p>\n

\uc9c8\ubcd1\uc744 \uce58\ub8cc\ud560 \uae30\ub300\ub97c \ubc1b\uace0 \uc788\ub294 \uc720\uc804\uc790 \uc694\ubc95<\/strong><\/p>\n

\ub610\ud55c \uc720\uc804\uc790 \uc694\ubc95\uc774 \ud608\uc6b0\ubcd1 \uce58\ub8cc\uc758 \uac00\ub2a5\uc131\uc73c\ub85c \uc5f0\uad6c\ub418\uace0 \uc788\uc2b5\ub2c8\ub2e4. 2022\ub144 5\uc6d4 24\uc77c, FDA\ub294 \ud608\uc6b0\ubcd1 B \uc720\uc804\uc790 \uc694\ubc95\uc5d0 \ub300\ud55c \uc5d0\ud2b8\ub77c\ub098\ucf54\uc9c4 \ub370\uc790\ud30c\ub974\ubcf4\ubca1\uc758 \uc6b0\uc120\uc21c\uc704 \uac80\ud1a0 \uc694\uccad\uc744 \uc218\ub77d\ud588\uc2b5\ub2c8\ub2e4 [4]. 2022\ub144 6\uc6d4 24\uc77c, \uc720\ub7fd \uc758\uc57d\ud488\uccad\uc740 \uc81c8\uc778\uc790 \uc5b5\uc81c\uc81c\uac00 \uc5c6\ub294 \uc911\uc99d \ud608\uc6b0\ubcd1 A \ud658\uc790\ub97c \uce58\ub8cc\ud558\uae30 \uc704\ud574 \ubc1c\ub85d\ud1a0\ucf54\uc9c4 \ub85d\uc0ac\ud30c\ubcf4\ubca1\uc5d0 \uc870\uac74\ubd80 \uc2b9\uc778\uc744 \uc2b9\uc778\ud560 \uac83\uc744 \uad8c\uace0\ud588\uc2b5\ub2c8\ub2e4. \ud604\uc7ac \uc720\ub7fd \uc704\uc6d0\ud68c\uc758 \uc2b9\uc778 \uacb0\uc815\uc744 \uc704\ud574 \ubcf4\ub958 \uc911\uc785\ub2c8\ub2e4 [5].<\/p>\n

\uc774\uac83\uc774 \uc2e4\ud5d8\uc2e4 \uc9c4\ub2e8\uc5d0 \ubb34\uc5c7\uc744 \uc758\ubbf8\ud569\ub2c8\uae4c?<\/h2>\n

\uc784\uc0c1 \uc2e4\ud5d8\uc2e4 \uc9c4\ub2e8\uc740 \ub2e4\uc591\ud55c \ud608\uc6b0\ubcd1 \uc694\ubc95\uc758 \ud6a8\uacfc\ub97c \ubaa8\ub2c8\ud130\ub9c1\ud558\ub294 \ub370 \uc911\uc694\ud55c \uc5ed\ud560\uc744 \ud569\ub2c8\ub2e4. \uc608\ub97c \ub4e4\uc5b4, \ub300\uccb4 \uc694\ubc95\uc744 \uc2dc\ud589\ud560 \ub54c \uc778\uc790 \ub18d\ucd95\uc561\uc758 \uc120\ud0dd\uc740 \uce21\uc815\uc5d0 \uc0ac\uc6a9\ub418\ub294 \ubd84\uc11d\ubc95\uc758 \uc120\ud0dd\uc5d0 \uc601\ud5a5\uc744 \ubbf8\uce58\uae30 \ub54c\ubb38\uc5d0 \uc911\uc694\ud569\ub2c8\ub2e4.<\/p>\n

\uc5d0\ubbf8\uc2dc\uc8fc\ub9d9\uacfc \uac19\uc740 \ube44\uc778\uc790 \uce58\ub8cc\uc81c\uc758 \ub3c4\uc785\uc73c\ub85c, \uc2e4\ud5d8\uc2e4\uc5d0\uc11c\ub294 \uba3c\uc800 \ub2e4\uc591\ud55c \uc720\ud615\uc758 \ubd84\uc11d\uc5d0 \ub300\ud55c \uce58\ub8cc\uc801 \uc791\uc6a9 \ubc29\uc2dd\uacfc \uc0dd\ud654\ud559\uc801 \uc601\ud5a5\uc744 \uc774\ud574\ud574\uc57c \ud569\ub2c8\ub2e4. \uadf8 \ud6c4, \ubaa8\ub2c8\ud130\ub9c1\uc5d0 \uac00\uc7a5 \uc801\ud569\ud55c \ubd84\uc11d\ubc95\uc744 \uc120\ud0dd\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4:<\/p>\n

\uce58\ub8cc\ubc95\uc758 \uc120\ud0dd\uacfc \uad00\uacc4\uc5c6\uc774 \uc5b5\uc81c\uc81c \uac1c\ubc1c\uc758 \uac00\ub2a5\uc131\uc740 \ub0a8\uc544\uc788\uc2b5\ub2c8\ub2e4. \uc784\uc0c1 \uc2e4\ud5d8\uc2e4\uc5d0\uc11c\ub294 \uc5b5\uc81c\uc81c\uac00 \uc694\ubc95\uc758 \ud6a8\uacfc\uc5d0 \uc601\ud5a5\uc744 \ubbf8\uce58\uae30 \ub54c\ubb38\uc5d0 \uc5b5\uc81c\uc81c \uac1c\ubc1c\uc744 \ubaa8\ub2c8\ud130\ub9c1\ud574\uc57c \ud569\ub2c8\ub2e4. \ub2e4\uc74c\uc740 \uc5b5\uc81c\uc81c \ud14c\uc2a4\ud2b8\uc5d0 \ub300\ud574 \uc8fc\uc758\ud574\uc57c \ud560 \uba87 \uac00\uc9c0 \uc0ac\ud56d\uc785\ub2c8\ub2e4.<\/p>\n

\ud608\uc7a5 \uc720\ub798 \ubc0f \uc7ac\uc870\ud569 \uc778\uc790 \uc0dd\uc131\ubb3c \ud615\ud0dc\uc758 \ub300\uccb4 \uc694\ubc95\uc774 \uc624\ub298\ub0a0 \ud608\uc6b0\ubcd1\uc758 \uc8fc\uc694 \uce58\ub8cc\ubc95\uc73c\ub85c \ub0a8\uc558\uc9c0\ub9cc, \uc0c8\ub85c\uc6b4 \uc57d\uc81c\uc758 \ubc1c\uacac\uc744 \uc704\ud55c \uc720\ub9dd\ud55c \uc5f0\uad6c\uac00 \ubd84\uba85\ud788 \uc9c4\ud589 \uc911\uc785\ub2c8\ub2e4. \uc774\ub7ec\ud55c \uc81c\uc81c\ub294 \uc751\uace0 \uce90\uc2a4\ucf00\uc774\ub4dc \uacfc\uc815\uc5d0 \uad00\uc5ec\ud558\ub294 \ub2e4\uc591\ud55c \ubd84\uc790 \uc57d\ubb3c \ud45c\uc801, \uc720\uc804\uc790 \ubc0f \ub2e8\ubc31\uc9c8\uc744 \uc0ac\uc6a9\ud569\ub2c8\ub2e4. \uc774 \uacb0\uacfc\ub294 \ud608\uc6b0\ubcd1 \uce58\ub8cc\ub97c \uc704\ud55c \uae38\uc774 \uac00\uae4c\uc6b4 \ubbf8\ub798\uc5d0 \uc874\uc7ac\ud560 \uc218 \uc788\ub2e4\ub294 \ud569\ub9ac\uc801\uc778 \ub099\uad00\ub860\uc744 \ubd88\ub7ec \uc77c\uc73c\ucf30\uc2b5\ub2c8\ub2e4 [6].<\/p>\n

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

[1] Centres for Disease Control and Prevention, Haemophilia Homepage-Inhibitors and Haemophilia https:\/\/www.cdc.gov\/ncbddd\/hemophilia\/inhibitors.html<\/p>\n

[2]<\/a> Mannucci, P., 2020. Hemophilia therapy: the future has begun. Haematologica, 105(3), pp.545-553.<\/p>\n

[3]<\/a> FDA approves emicizumab-kxwh for prevention and reduction of bleeding in patients with hemophilia A with factor VIII inhibitors. https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-approves-emicizumab-kxwh-prevention-and-reduction-bleeding-patients-hemophilia-factor-viii<\/p>\n

[4]<\/a> CSL Behring gene therapy makes comeback after hold for FDA priority review. https:\/\/www.fiercebiotech.com\/biotech\/2020-trial-pause-isnt-holding-csl-behring-back-fda-oks-priority-review-application<\/p>\n

[5]<\/a> BioMarin\u2019s haemophilia gene therapy Roctavian wins conditional EU backing amid FDA delay. https:\/\/www.fiercepharma.com\/pharma\/biomarins-hemophilia-gene-therapy-roctavian-wins-conditional-eu-backing-fda-plan-delayed<\/p>\n

[6] <\/a>World Federation of Haemophilia Guidelines for the Management of Haemophilia. https:\/\/www1.wfh.org\/publications\/files\/pdf-1863.pdf<\/p>\n

[7] National Haemophilia Foundation for all bleeding disorders-current treatments. https:\/\/www.hemophilia.org\/bleeding-disorders-a-z\/treatment\/current-treatments<\/p>\n

[8]<\/a> World Federation of Haemophilia Guidelines for the Management of Haemophilia. https:\/\/www1.wfh.org\/publications\/files\/pdf-1863.pdf<\/p>\n","protected":false},"excerpt":{"rendered":"

\uc774 \uae30\uc0ac\ub294 \ud608\uc6b0\ubcd1 \uc9c4\ub2e8 \ubc0f \uce58\ub8cc\ubc95\uc5d0 \uad00\ud55c \uc2dc\ub9ac\uc988\uc758 \ud30c\ud2b8 2\uc785\ub2c8\ub2e4. \uc5ec\uae30\uc5d0\uc11c \ubcfc \uc218\uc788\ub294 \uccab \ubc88\uc9f8 \uae30\uc0ac\ub294 \uc784\uc0c1 \ud45c\ud604, \uc9c4\ub2e8 \ubc0f \uce58\ub8cc\uc5d0 \ub300\ud55c \uac1c\uc694\ub97c \uc81c\uacf5\ud569\ub2c8\ub2e4. \uc5f0\uad6c\uc790\ub4e4\uc774 \ud608\uc6b0\ubcd1\uc5d0 \ub300\ud55c \ud601\uc2e0\uc801\uc778 \uc0c8\ub85c\uc6b4 \uce58\ub8cc\ubc95\uc744 \uac1c\ubc1c\ud568\uc5d0 \ub530\ub77c \uc784\uc0c1 \uc2e4\ud5d8\uc2e4 \uc804\ubb38\uac00\ub294 \uc774\ub7ec\ud55c \ubc1c\uc804\uacfc \uc9c4\ub2e8 \uc6cc\ud06c\ud50c\ub85c\uc5d0 \ub300\ud55c \uc7a0\uc7ac\uc801 \uc601\ud5a5\uc744 \uc54c\uace0 \uc788\uc5b4\uc57c \ud569\ub2c8\ub2e4. \uc774 \uae30\uc0ac\uc5d0\uc11c\ub294 \uba87 \uac00\uc9c0 \uc0c8\ub85c\uc6b4 \uce58\ub8cc \uc591\uc2dd\uacfc \uc2e4\ud5d8\uc2e4 \uc758\ud559\uc5d0 \ub300\ud55c 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