{"id":45168,"date":"2022-06-16T17:01:33","date_gmt":"2022-06-16T15:01:33","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/lg-chems-new-drug-for-obesity-receives-additional-orphan-drug-designation-by-the-us-fda\/"},"modified":"2022-06-16T17:01:33","modified_gmt":"2022-06-16T15:01:33","slug":"lg-chems-new-drug-for-obesity-receives-additional-orphan-drug-designation-by-the-us-fda","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/lg-chems-new-drug-for-obesity-receives-additional-orphan-drug-designation-by-the-us-fda\/","title":{"rendered":"LG Chem\u2019s New Drug for Obesity Receives Additional Orphan Drug Designation by the US FDA"},"content":{"rendered":"<div>\n<ul class=\"bwlistdisc\">\n<li class=\"bwcellpmargin\">\n<b>LB54640 additionally designated for the rare obesity disorder \u2018POMC deficiency\u2019 followed by \u2018LEPR deficiency\u2019<\/b>\n<\/li>\n<\/ul>\n<p class=\"bwmarginl1\">\n&#8211; Novel small molecule agonist for MC4R, a protein involved in signaling satiety to suppress appetite\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\n<b>LG Chem gains momentum to target the rare obesity market in the US<\/b>\n<\/li>\n<\/ul>\n<ul class=\"bwlistdisc\">\n<li>\n<b>US Phase 1 results to be announced within this year and global Phase 2\/3 to be initiated in 2023<\/b>\n<\/li>\n<\/ul>\n<p>SEOUL, South Korea &amp; CAMBRIDGE, Mass.&#8211;(BUSINESS WIRE)&#8211;LG Chem\u2019s new drug for treating genetic obesity received additional ODD (Orphan Drug Designation) by the US FDA.\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20220616005684\/en\/1489213\/5\/LG_Chem_LOGO.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20220616005684\/en\/1489213\/21\/LG_Chem_LOGO.jpg\"><\/a><\/p>\n<p>\nLG Chem announced on 16th that the FDA recently granted ODD to \u2018LB54640\u2019 for the treatment of \u2018POMC (Proopiomelanocortin) deficiency.\u2019\n<\/p>\n<p>\n\u2018LB54640\u2019 also received ODD back in September of 2020 by the FDA for \u2018LEPR (leptin receptor) deficiency\u2019.\n<\/p>\n<p>\nThe FDA operates the ODD system to encourage and support the development of rare and difficult-to-treat disease drugs with prevalence rates of less than 200,000 people. It is estimated that there are about 120,000 people suffering from rare genetic obesity in the US.\n<\/p>\n<p>\nWith this designation, LG Chem will receive benefits such as exclusive sales rights in the US market for seven years, subsidies and tax cuts for clinical trial expenses in the US, and preliminary consulting support related to development.\n<\/p>\n<p>\n\u2018LB54640\u2019 is an oral drug administered once a day which targets the pathway of the protein MC4R (Melanocortin 4 Receptor). A special feature of \u2018LB54640\u2019 is its ability to suppress appetite by directly activating MC4R, which sends the final signal for satiety, even when MC4R\u2019s upper pathway genes (\u2018LEPR,\u2019 \u2018POMC,\u2019 etc.) are defective. LG Chem plans to present a distinguished new oral drug that improves convenience in the rare obesity market where only injectable treatments are currently available.\n<\/p>\n<p>\nLG Chem recently completed Phase 1 trial of \u2018LG54640\u2019 in the US for healthy overweight adults without genetic defects, and plans to announce the detailed clinical results within this year. Accordingly, global Phase 2\/3 trial will begin for patients with LEPR or POMC deficiency genetic obesity disorder starting next year.\n<\/p>\n<p>\nMeanwhile, according to the global market research institute EvaluatePharma, the US market for genetic obesity medicine will grow rapidly from 28 million USD in 2022 to about 800 million USD by 2028 due to the development and broader accessibility of genetic diagnostic testing technologies.\n<\/p>\n<p>\n<b>About LG Chem Life Sciences<\/b>\n<\/p>\n<p>\nLG Chem Life Sciences is a business division within LG Chem, engaged in development, manufacturing, and global commercialization of pharmaceutical products. LG Chem Life Sciences seeks to expand and make global presence by focusing on key core therapeutic areas of Immunology, Oncology, and Metabolic Diseases (specifically, diabetes and related metabolic diseases). To achieve such, its strategy is to actively pursue global collaboration encompassing from asset-centric to strategic investment and collaboration.\n<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\n<span class=\"bwuline\">LG Chem Life Sciences Innovation Center<\/span><br \/>General Inquiries: <a target=\"_blank\" href=\"&#109;&#97;&#x69;l&#116;&#x6f;&#x3a;c&#111;&#x6e;&#x74;a&#99;&#x74;&#x2e;c&#98;&#x6c;&#x40;l&#103;&#x63;&#x68;e&#109;&#x2e;c&#111;&#109;\" rel=\"nofollow noopener\" shape=\"rect\">&#99;&#x6f;&#x6e;t&#97;&#x63;t&#46;&#x63;&#x62;&#108;&#x40;&#x6c;g&#99;&#x68;e&#109;&#x2e;&#x63;&#111;&#x6d;<\/a><br \/>Partners: <a target=\"_blank\" href=\"&#109;&#x61;&#105;&#x6c;t&#111;&#x3a;&#112;&#x61;r&#x74;n&#101;&#x72;&#115;&#x2e;c&#x62;&#x6c;&#64;&#x6c;g&#x63;h&#101;&#x6d;&#46;&#x63;o&#x6d;\" rel=\"nofollow noopener\" shape=\"rect\">&#112;&#x61;&#114;&#x74;&#110;&#x65;&#114;&#x73;&#46;&#x63;&#98;&#x6c;&#64;&#x6c;&#103;&#x63;&#104;&#x65;&#109;&#x2e;&#99;&#x6f;&#109;<\/a><br \/>Media (Jiin Chung): <a target=\"_blank\" href=\"&#x6d;&#97;i&#x6c;&#116;o&#x3a;&#109;e&#x64;&#105;a&#x2e;&#99;b&#x6c;&#64;l&#x67;&#99;h&#x65;&#109;&#46;&#x63;&#111;m\" rel=\"nofollow noopener\" shape=\"rect\">&#x6d;&#x65;&#x64;&#105;&#97;&#46;c&#x62;&#x6c;&#x40;&#108;&#103;ch&#x65;&#x6d;&#x2e;&#99;&#111;m<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>LB54640 additionally designated for the rare obesity disorder \u2018POMC deficiency\u2019 followed by \u2018LEPR deficiency\u2019 &#8211; Novel small molecule agonist for MC4R, a protein involved in signaling satiety to suppress appetite LG Chem gains momentum to target the rare obesity market in the US US Phase 1 results to be announced within this year and global &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/lg-chems-new-drug-for-obesity-receives-additional-orphan-drug-designation-by-the-us-fda\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-45168","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>LG Chem\u2019s New Drug for Obesity Receives Additional Orphan Drug Designation by the US FDA - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/lg-chems-new-drug-for-obesity-receives-additional-orphan-drug-designation-by-the-us-fda\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"LG Chem\u2019s New Drug for Obesity Receives Additional Orphan Drug Designation by the US FDA - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"LB54640 additionally designated for the rare obesity disorder \u2018POMC deficiency\u2019 followed by \u2018LEPR deficiency\u2019 &#8211; Novel small molecule agonist for MC4R, a protein involved in signaling satiety to suppress appetite LG Chem gains momentum to target the rare obesity market in the US US Phase 1 results to be announced within this year and global ... 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