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  • FDA grants ODD to LG Chem¡¯s oral genetic obesity drug
  • by Chon, Seung-Hyun | translator Alice Kang | Jun 20, 2022 06:03am
oral genetic obesity drug, LB54640
Second to receive FDA orphan drug designation after the first in 2020¡¦ will receive benefits including 7-year marketing exclusivity upon FDA approval
LG Chem announced on the 16th that the US Food and Drug Administration has been additionally granted orphan drug status to its new genetic obesity drug ¡®LB54640.¡¯

The FDA has recently designated LB54640 as an orphan drug for the treatment of pro-opiomelanocortin (POMC) deficiency.¡¯

The FDA has been operating an Orphan Drug Designation (ODD) system to encourage and support the development of treatments for rare and intractable diseases that affect less than 200,000 persons in the US. The number of POMC patients suffering from genetic obesity in the US is estimated to be around 120,000.

With the designation, LG Chem will be receiving benefits such as 7-year marketing exclusivity in the US market, support f
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