MFDS Grants First Domestic Approval for Itch Treatment of 'Alagille Syndrome'

Green Cross Imported Rare Drug 'Livmaliac'

The Ministry of Food and Drug Safety announced on the 28th that it has approved GC Green Cross's imported rare drug 'Livmali-aek (Maralixibet Chloride)'.

This drug is used to treat cholestatic pruritus in patients aged 1 year and older with Alagille syndrome. Alagille syndrome is a disease characterized by a significant reduction in the number of bile ducts within the liver, causing bile to accumulate without being excreted from the liver, accompanied by disorders of the cardiovascular system, skeletal system, eyes, and skin.

This drug acts as an inhibitor of the 'sodium-dependent bile acid transporter' on the surface of the intestinal (small intestine) tract, blocking the reabsorption of bile acids and increasing the excretion of bile acids in the feces, thereby lowering the bile acid levels in the bile ducts within the liver.

In particular, as the first domestic treatment available for pruritus in patients with Alagille syndrome, it is expected to help patients suffering from related skin itching.

Oh Yu-kyung, Commissioner of the Ministry of Food and Drug Safety, stated, "We will continue to promptly review and approve the safety and efficacy of rare drugs to expand and guarantee treatment opportunities for patients with rare and intractable diseases, and continuously promote safety innovation."

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