Patients with a rare liver disease who have not responded well to existing treatments now have a new option. The Ministry of Food and Drug Safety said on the 20th that it had approved Livdelzi (seladelpar lysine dihydrate), an imported orphan drug used to treat primary biliary cholangitis.
Primary biliary cholangitis is a rare, chronic and progressive disease in which bile ducts inside the liver are destroyed, allowing bile acids and other toxic substances to build up and damage the organ.
Livdelzi acts on peroxisome proliferator-activated receptor delta (PPARδ), a nuclear receptor inside cells, to reduce the liver's production of bile acids. It is indicated for adult patients with primary biliary cholangitis who cannot tolerate existing treatments or who respond inadequately to them.
An official at the ministry said the drug would expand treatment options for patients with primary biliary cholangitis who had been difficult to treat with existing therapies.
The ministry also approved Jascayd, a treatment for idiopathic pulmonary fibrosis, and Qinlock 50 mg, a treatment for gastrointestinal stromal tumors, earlier this month.