LG Chem's Obesity Treatment New Drug 'LB54640' Designated as Rare Disease Drug by US FDA

LEPR Deficiency Followed by Addition of POMC Deficiency Designation

[Asia Economy Reporter Lee Gwan-ju] LG Chem's new drug for hereditary obesity treatment has been additionally designated as an Orphan Drug (ODD) by the U.S. Food and Drug Administration (FDA).

LG Chem announced on the 16th that the FDA recently designated 'LB54640' as an orphan drug for the treatment of 'POMC (Proopiomelanocortin) deficiency.' LB54640 had previously received FDA orphan drug designation in September 2020 for 'LEPR (Leptin Receptor) deficiency.'

With this designation, LG Chem will receive benefits such as seven years of exclusive sales rights in the U.S. market, support for clinical trial costs within the U.S., tax reductions, and pre-development consultation support.

LB54640 is a once-daily oral treatment targeting the MC4R (Melanocortin-4 Receptor) signaling pathway, a protein involved in satiety. Even if there are defects in upstream genes of MC4R (such as LEPR or POMC), it directly acts on the MC4R protein that ultimately transmits satiety signals, thereby inducing appetite suppression.

LG Chem recently completed a Phase 1 clinical trial of LB54640 in healthy overweight adults without genetic defects in the U.S. and plans to announce detailed clinical results within this year. Subsequently, starting next year, it plans to initiate global Phase 2 and 3 trials targeting hereditary obesity patients with LEPR or POMC deficiency.

Meanwhile, the FDA operates the orphan drug designation system to encourage and support the development of treatments for rare and intractable diseases with a prevalence of fewer than 200,000 patients. It is estimated that there are about 120,000 rare hereditary obesity patients in the U.S. According to the global market research firm EvaluatePharma, the U.S. market for hereditary obesity treatments is expected to grow from $28 million (approximately 36 billion KRW) this year to $800 million (approximately 1 trillion KRW) by 2028.

This content was produced with the assistance of AI translation services.