SEOUL, South Korea & CAMBRIDGE, Mass.–(BUSINESS WIRE)–LG Chem’s new drug for treating genetic obesity received additional ODD (Orphan Drug Designation) by the US FDA.
LG Chem announced on 16th that the FDA recently granted ODD to ‘LB54640’ for the treatment of ‘POMC (Proopiomelanocortin) deficiency.’
‘LB54640’ also received ODD back in September of 2020 by the FDA for ‘LEPR (leptin receptor) deficiency’.
The 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.
With 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.
‘LB54640’ is an oral drug administered once a day which targets the pathway of the protein MC4R (Melanocortin 4 Receptor). A special feature of ‘LB54640’ is its ability to suppress appetite by directly activating MC4R, which sends the final signal for satiety, even when MC4R’s upper pathway genes (‘LEPR,’ ‘POMC,’ 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.
LG Chem recently completed Phase 1 trial of ‘LG54640’ 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.
Meanwhile, 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.
About LG Chem Life Sciences
LG 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.