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.
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