{"id":24714,"date":"2025-11-28T11:31:06","date_gmt":"2025-11-28T11:31:06","guid":{"rendered":"https:\/\/itbusinesstoday.com\/?p=24714"},"modified":"2025-11-28T12:46:26","modified_gmt":"2025-11-28T12:46:26","slug":"eisai-seeks-approval-for-subcutaneous-leqembi-in-japan","status":"publish","type":"post","link":"https:\/\/itbusinesstoday.com\/ja\/health-tech\/pharma\/eisai-seeks-approval-for-subcutaneous-leqembi-in-japan\/","title":{"rendered":"LEQEMBI\u76ae\u4e0b\u6ce8\u88fd\u5264\u306e\u65e5\u672c\u306b\u304a\u3051\u308b\u88fd\u9020\u8ca9\u58f2\u627f\u8a8d\u7533\u8acb\u306b\u3064\u3044\u3066"},"content":{"rendered":"

\u30a8\u30fc\u30b6\u30a4<\/a> \u3068\u305d\u306e\u30b0\u30ed\u30fc\u30d0\u30eb\u30fb\u30d1\u30fc\u30c8\u30ca\u30fc \u30d0\u30a4\u30aa\u30b8\u30a7\u30f3<\/a> \u5f53\u793e\u306f\u3001\u3053\u306e\u305f\u3073\u3001\u6297\u30a2\u30df\u30ed\u30a4\u30c9\u5264\u300cLEQEMBI\uff08\u30ec\u30b1\u30f3\u30d3\uff09\u300d\u306e\u76ae\u4e0b\u6ce8\u88fd\u5264\uff08SC-AI\uff09\u306b\u3064\u3044\u3066\u3001\u65e9\u671f\u30a2\u30eb\u30c4\u30cf\u30a4\u30de\u30fc\u578b\u8a8d\u77e5\u75c7\u6cbb\u7642\u5264\u3068\u3057\u3066\u3001\u72ec\u7acb\u884c\u653f\u6cd5\u4eba\u533b\u85ac\u54c1\u533b\u7642\u6a5f\u5668\u7dcf\u5408\u6a5f\u69cb\u306b\u88fd\u9020\u8ca9\u58f2\u627f\u8a8d\u7533\u8acb\u3092\u884c\u3044\u307e\u3057\u305f\u3002\u3053\u306e\u88fd\u5264\u304c\u627f\u8a8d\u3055\u308c\u308c\u3070\u3001\u60a3\u8005\u306f\u5f53\u521d\u304b\u3089\u81ea\u5b85\u3067\u6ce8\u5c04\u3092\u53d7\u3051\u308b\u3053\u3068\u304c\u53ef\u80fd\u3068\u306a\u308a\u3001\u5f93\u6765\u306e\u70b9\u6ef4\u9759\u6ce8\u7642\u6cd5\u304b\u3089\u306e\u5927\u304d\u306a\u8ee2\u63db\u3068\u306a\u308a\u307e\u3059\u3002.<\/p>\n

\u7b2c3\u76f8\u300cClarity AD\u300d\u975e\u76f2\u691c\u5ef6\u9577\u8a66\u9a13\u306e\u30c7\u30fc\u30bf\u306f\u3001\u672c\u7533\u8acb\u3092\u652f\u6301\u3059\u308b\u3082\u306e\u3067\u3059\u3002500mg\u306e\u90311\u56de\u306e\u76ae\u4e0b\u6295\u4e0e\uff08250mg\u306e\u6ce8\u5c04\u30922\u56de\u4f7f\u7528\uff09\u306f\u3001\u9759\u8108\u5185\u6295\u4e0e\u3068\u540c\u69d8\u306e\u30ec\u30d9\u30eb\u3068\u7d50\u679c\u3092\u3082\u305f\u3089\u3057\u307e\u3059\u3002\u5b89\u5168\u6027\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u3082\u826f\u597d\u3067\u3059\u3002\u5168\u8eab\u6027\u8f38\u6db2\u306b\u5bfe\u3059\u308b\u53cd\u5fdc\u306f2%\u672a\u6e80\u3067\u3059\u3002.<\/p>\n

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\u76ae\u4e0bLEQEMBI\u306f\u3001\u6a19\u6e96\u7684\u306a\u9759\u8108\u5185\u6295\u4e0e\u6cd5\u3088\u308a\u3082\u91cd\u8981\u306a\u5229\u70b9\u304c\u3042\u308b\u304b\u3082\u3057\u308c\u307e\u305b\u3093\uff1a<\/p>\n

\u5229\u4fbf\u6027\u3068\u5feb\u9069\u6027<\/strong>:\u81ea\u5b85\u3067\u6ce8\u5c04\u3092\u6253\u3064\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u30022\u9031\u9593\u3054\u3068\u306b\u901a\u9662\u3059\u308b\u5fc5\u8981\u306f\u3042\u308a\u307e\u305b\u3093\u3002.<\/p>\n

\u4f7f\u7528\u3059\u308b\u533b\u7642\u8cc7\u6e90\u306e\u6e1b\u5c11<\/strong>:SC-AI\u306f\u6cbb\u7642\u3092\u7c21\u7d20\u5316\u3057\u307e\u3059\u3002\u8f38\u6db2\u306e\u524d\u6e96\u5099\u3092\u7701\u304d\u3001\u770b\u8b77\u5e2b\u306e\u76e3\u8996\u3092\u524a\u6e1b\u3057\u3001\u75c5\u9662\u306e\u624b\u9806\u3092\u5408\u7406\u5316\u3057\u307e\u3059\u3002.<\/p>\n

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\u88fd\u85ac\u696d\u754c\u306b\u3068\u3069\u307e\u3089\u306a\u3044\u5e83\u7bc4\u306a\u5f71\u97ff\uff1a\u65e5\u672c\u306b\u304a\u3051\u308b\u6280\u8853\u3001\u30c7\u30fc\u30bf\u3001\u30d8\u30eb\u30b9\u30b1\u30a2\u30b5\u30fc\u30d3\u30b9\u306e\u610f\u5473\u3059\u308b\u3082\u306e<\/strong><\/h4>\n

\u4eca\u56de\u306e\u767a\u8868\u306f\u533b\u85ac\u54c1\u958b\u767a\u306b\u7126\u70b9\u3092\u5f53\u3066\u305f\u3082\u306e\u3067\u3059\u3002\u307e\u305f\u3001\u65e5\u672c\u306e\u30cf\u30a4\u30c6\u30af\u7523\u696d\u3001\u30c7\u30fc\u30bf\u30a4\u30f3\u30d5\u30e9\u3001\u533b\u7642\u30b5\u30fc\u30d3\u30b9\u306b\u3082\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\uff1a<\/p>\n

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\u5728\u5b85\u6ce8\u5c04\u306b\u3088\u308b\u30a2\u30eb\u30c4\u30cf\u30a4\u30de\u30fc\u6cbb\u7642\u304c\u5897\u52a0\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u30c7\u30b8\u30bf\u30eb\u30d8\u30eb\u30b9\u30c4\u30fc\u30eb\u306e\u30cb\u30fc\u30ba\u304c\u9ad8\u307e\u308a\u307e\u3059\u3002\u9060\u9694\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u30b7\u30b9\u30c6\u30e0\u3001\u9060\u9694\u533b\u7642\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u3001\u30b1\u30a2\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30a2\u30d7\u30ea\u306a\u3069\u304c\u3053\u308c\u306b\u3042\u305f\u308a\u307e\u3059\u3002\u30cf\u30a4\u30c6\u30af\u4f01\u696d\u306f\u65b0\u305f\u306a\u6210\u9577\u6a5f\u4f1a\u3092\u898b\u51fa\u3059\u3067\u3057\u3087\u3046\u3002\u7279\u306b\u3001\u9ad8\u9f62\u8005\u30b1\u30a2\u3001\u9060\u9694\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3001\u60a3\u8005\u30c7\u30fc\u30bf\u7ba1\u7406\u3067\u9855\u8457\u3067\u3059\u3002.<\/p>\n

\u30c7\u30fc\u30bf\u3068AI\u306b\u3088\u308b\u30a2\u30eb\u30c4\u30cf\u30a4\u30de\u30fc\u75c5\u30b1\u30a2 <\/strong><\/p>\n

\u81ea\u5b85\u3084\u8a3a\u7642\u6240\u3067\u306e\u6cbb\u7642\u304c\u5897\u3048\u3066\u3044\u307e\u3059\u3002\u305d\u306e\u305f\u3081\u3001\u30c7\u30fc\u30bf\u3092\u53ce\u96c6\u3001\u7ba1\u7406\u3001\u5206\u6790\u3059\u308b\u305f\u3081\u306e\u3088\u308a\u826f\u3044\u65b9\u6cd5\u304c\u5fc5\u8981\u3067\u3059\u3002\u3053\u306e\u30c7\u30fc\u30bf\u306f\u3001\u60a3\u8005\u304c\u6cbb\u7642\u8a08\u753b\u306b\u3069\u308c\u3060\u3051\u5f93\u3063\u3066\u3044\u308b\u304b\u3092\u8ffd\u8de1\u3059\u308b\u3082\u306e\u3067\u3059\u3002\u307e\u305f\u3001\u526f\u4f5c\u7528\u306e\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3082\u884c\u3044\u307e\u3059\u3002\u3053\u3053\u3067\u306f\u60a3\u8005\u304b\u3089\u306e\u30d5\u30a3\u30fc\u30c9\u30d0\u30c3\u30af\u304c\u9375\u3068\u306a\u308b\u3067\u3057\u3087\u3046\u3002AI\u30d9\u30fc\u30b9\u306e\u533b\u7642\u30c7\u30fc\u30bf\u30fb\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u3001\u96fb\u5b50\u30ab\u30eb\u30c6\u30fb\u30d7\u30ed\u30d0\u30a4\u30c0\u3001AI\u8a3a\u65ad\u30c4\u30fc\u30eb\u306f\u3001\u304a\u305d\u3089\u304f\u5927\u304d\u304f\u6210\u9577\u3059\u308b\u3067\u3057\u3087\u3046\u3002.<\/p>\n

\u30a4\u30f3\u30d5\u30e9\u3068\u4f9b\u7d66<\/strong>-\u30c1\u30a7\u30fc\u30f3\u30fb\u30a4\u30f3\u30d1\u30af\u30c8<\/strong><\/p>\n

SC\u30aa\u30fc\u30c8\u30a4\u30f3\u30b8\u30a7\u30af\u30bf\u30fc\u3078\u306e\u30b7\u30d5\u30c8\u306f\u3001\u75c5\u9662\u5916\u3067\u306e\u4fdd\u7ba1\u3001\u6d41\u901a\u3001\u6295\u4e0e\u304c\u53ef\u80fd\u306a\u305f\u3081\u3001\u533b\u7642\u7528\u54c1\u306e\u7ba1\u7406\u65b9\u6cd5\u3092\u5909\u3048\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u3001\u5728\u5b85\u6cbb\u7642\u304c\u4e00\u822c\u7684\u306b\u306a\u308b\u306b\u3064\u308c\u3066\u3001\u7269\u6d41\u3001\u30b3\u30fc\u30eb\u30c9\u30c1\u30a7\u30fc\u30f3\u7ba1\u7406\u3001\u533b\u7642\u6a5f\u5668\u88fd\u9020\u3001\u533b\u85ac\u54c1\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306b\u643a\u308f\u308b\u4f01\u696d\u306e\u9700\u8981\u304c\u9ad8\u307e\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n

\u9ad8\u9f62\u8005\u4ecb\u8b77\u30b5\u30fc\u30d3\u30b9\u3068\u30a4\u30f3\u30b7\u30e5\u30a2\u30c6\u30c3\u30af\u306b\u5f3e\u307f<\/strong><\/p>\n

\u6211\u304c\u56fd\u306f\u9ad8\u9f62\u5316\u7387\u304c\u9ad8\u3044\u305f\u3081\u3001\u30a2\u30eb\u30c4\u30cf\u30a4\u30de\u30fc\u75c5\u30b1\u30a2\u306e\u9769\u65b0\u306b\u304a\u3044\u3066\u4e16\u754c\u3092\u30ea\u30fc\u30c9\u3057\u3066\u3044\u307e\u3059\u3002\u5728\u5b85\u4ecb\u8b77\u304c\u4e00\u822c\u7684\u306b\u306a\u308b\u65e5\u3082\u8fd1\u3044\u304b\u3082\u3057\u308c\u307e\u305b\u3093\u3002\u3053\u306e\u30b7\u30d5\u30c8\u306b\u3088\u308a\u3001\u5b8c\u5168\u306a\u5728\u5b85\u4ecb\u8b77\u30b5\u30fc\u30d3\u30b9\u3001\u9060\u9694\u4ecb\u8b77\u8005\u30b5\u30dd\u30fc\u30c8\u3001\u9577\u671f\u795e\u7d4c\u30b1\u30a2\u306b\u7279\u5316\u3057\u305f\u533b\u7642\u4fdd\u967a\u306e\u30cb\u30fc\u30ba\u304c\u9ad8\u307e\u308b\u3067\u3057\u3087\u3046\u3002\u30a4\u30f3\u30b7\u30e5\u30a2\u30c6\u30c3\u30af\u4f01\u696d\u3084\u4ecb\u8b77\u6280\u8853\u30d7\u30ed\u30d0\u30a4\u30c0\u30fc\u306f\u3001\u3053\u306e\u62e1\u5927\u3059\u308b\u5e02\u5834\u306b\u53c2\u5165\u3059\u308b\u6e96\u5099\u304c\u6574\u3063\u3066\u3044\u307e\u3059\u3002.<\/p>\n

\u30af\u30ed\u30b9<\/strong>-\u7523\u696d\u754c\u306e\u5354\u529b\u304c\u4e0d\u53ef\u6b20\u306b<\/strong><\/p>\n

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\u8ab2\u984c\u3068\u8003\u5bdf<\/strong><\/h4>\n

\u898f\u5236\u5f53\u5c40\u306e\u5be9\u67fb\u30ea\u30b9\u30af\uff1a\u627f\u8a8d\u306f\u4fdd\u8a3c\u3055\u308c\u3066\u3044\u307e\u305b\u3093\u3002PMDA\u306f\u5b89\u5168\u6027\u3001\u6709\u52b9\u6027\u3001SC\u6295\u4e0e\u304c\u5b9f\u751f\u6d3b\u3067\u3069\u306e\u7a0b\u5ea6\u6a5f\u80fd\u3059\u308b\u304b\u3092\u8abf\u3079\u307e\u3059\u3002.<\/p>\n

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\u30a4\u30f3\u30d5\u30e9\u3068\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u306b\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u3001\u5728\u5b85\u30b1\u30a2\u306e\u30ed\u30b8\u30b9\u30c6\u30a3\u30af\u30b9\u3001\u4ecb\u8b77\u8005\u306e\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u3001\u533b\u7642\u5ec3\u68c4\u7269\u306e\u7ba1\u7406\u306a\u3069\u304c\u542b\u307e\u308c\u307e\u3059\u3002.<\/p>\n

\u8ee2\u6a5f\u3068\u306a\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u7406\u7531<\/strong><\/h4>\n

SC-AI\u7248LEQEMBI\u306e\u627f\u8a8d\u306b\u3088\u308a\u3001\u30a2\u30eb\u30c4\u30cf\u30a4\u30de\u30fc\u75c5\u6cbb\u7642\u3078\u306e\u30a2\u30af\u30bb\u30b9\u304c\u5411\u4e0a\u3057\u307e\u3059\u3002\u3053\u306e\u753b\u671f\u7684\u306a\u6280\u8853\u306f\u3001\u5728\u5b85\u4ecb\u8b77\u3092\u5bb9\u6613\u306b\u3057\u307e\u3059\u3002\u60a3\u8005\u3068\u4ecb\u8b77\u8005\u306e\u8ca0\u62c5\u3092\u8efd\u6e1b\u3057\u307e\u3059\u3002\u81ea\u5b85\u3067\u306e\u81ea\u5df1\u6295\u4e0e\u306f\u30b9\u30c8\u30ec\u30b9\u3092\u8efd\u6e1b\u3057\u3001\u751f\u6d3b\u306e\u8cea\u3092\u5411\u4e0a\u3055\u305b\u3001\u9577\u671f\u7684\u306a\u6cbb\u7642\u3092\u5bb9\u6613\u306b\u3057\u307e\u3059\u3002\u3053\u306e\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u306f\u3001\u30d8\u30eb\u30b9\u30b1\u30a2\u3068\u30c6\u30af\u30ce\u30ed\u30b8\u30fc\u306e\u878d\u5408\u3092\u652f\u63f4\u3057\u307e\u3059\u3002\u65e5\u672c\u306e\u9ad8\u9f62\u5316\u793e\u4f1a\u306b\u304a\u3051\u308b\u533b\u7642\u3068\u30c7\u30b8\u30bf\u30eb\u30c4\u30fc\u30eb\u306e\u878d\u5408\u3002.<\/p>\n

\u305d\u306e\u305f\u3081\u3001\u3053\u306e\u958b\u767a\u306f\u4e00\u822c\u7684\u306a\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u306e\u89e6\u5a92\u3068\u3057\u3066\u6a5f\u80fd\u3057\u3001\u7d50\u679c\u3068\u3057\u3066\u30c7\u30b8\u30bf\u30eb\u30d8\u30eb\u30b9\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u3001\u9060\u9694\u30b1\u30a2\u3001AI\u306b\u3088\u308b\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3001\u652f\u63f4\u30a4\u30f3\u30d5\u30e9\u306e\u6210\u9577\u3092\u4fc3\u9032\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>","protected":false},"excerpt":{"rendered":"

Eisai and its global partner Biogen have filed a new drug application with Japan’s Pharmaceuticals and Medical Devices Agency seeking approval of a subcutaneous version, SC\u2011AI, of its anti\u2011amyloid LEQEMBI for the treatment of early Alzheimer’s disease. If approved, this version would permit patients to receive injections at home from the outset-a major shift from the existing intravenous regimen. Data from the Phase 3 “Clarity AD” open-label extension supports the application. Weekly subcutaneous dosing of 500 mg, using two 250 mg injections, provides similar levels and results as IV dosing. It has a strong safety profile. Less than 2% of patients have reactions to systemic infusions. If approved, LEQEMBI will […]<\/p>\n","protected":false},"author":7,"featured_media":24740,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_bbp_topic_count":0,"_bbp_reply_count":0,"_bbp_total_topic_count":0,"_bbp_total_reply_count":0,"_bbp_voice_count":0,"_bbp_anonymous_reply_count":0,"_bbp_topic_count_hidden":0,"_bbp_reply_count_hidden":0,"_bbp_forum_subforum_count":0,"wprm-recipe-roundup-name":"","wprm-recipe-roundup-description":"","postBodyCss":"","postBodyMargin":[],"postBodyPadding":[],"postBodyBackground":{"backgroundType":"classic","gradient":""},"footnotes":""},"categories":[89,8098,182],"tags":[872,7394,1715,7393,424],"ppma_author":[572],"class_list":{"0":"post-24714","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-health-tech","8":"category-news-articles","9":"category-pharma","10":"tag-alzheimer-disease","11":"tag-biogen","12":"tag-eisai","13":"tag-leqembi","14":"tag-pharma"},"yoast_head":"\nEisai Pursues Approval of LEQEMBI Shot for Alzheimer\u2019s<\/title>\n<meta name=\"description\" content=\"Eisai and Biogen seek Japan approval for subcutaneous LEQEMBI, allowing at-home injections for early Alzheimer\u2019s treatment.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/itbusinesstoday.com\/ja\/health-tech\/pharma\/eisai-seeks-approval-for-subcutaneous-leqembi-in-japan\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Eisai Pursues Approval of LEQEMBI Shot for Alzheimer\u2019s\" \/>\n<meta property=\"og:description\" content=\"Eisai and Biogen seek Japan approval for subcutaneous LEQEMBI, allowing at-home injections for early Alzheimer\u2019s treatment.\" \/>\n<meta property=\"og:url\" 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