Ursodeoxycholic Acid

The FDA granted accelerated approval to Ipsen Pharma’s Iqirvo 80 mg, a first-in-class oral, once-daily peroxisome proliferator-activated receptor agonist for the treatment of primary biliary cholangitis, according to a company release.

Patients with primary biliary cholangitis who received bezafibrate after incomplete response to ursodeoxycholic acid showed lower risk for death or liver transplant, according to a presenter at the Digital International Liver Congress.

While the absolute clinical efficacy of ursodeoxycholic acid for primary biliary cholangitis varied by baseline prognostic characteristics, study results showed generally high rates of liver transplant-free survival and overall survival.

CymaBay Therapeutics achieved its targeted patient enrollment for the EHANCE trial, a phase 3 study of seladelpar for primary biliary cholangitis, and that the company is on track to complete full enrollment by the end of November.

Primary biliary cholangitis is a chronic autoimmune disease that causes progressive destruction of the bile ducts. While the disease is considered rare with fewer than 200,000 cases in the U.S. per year, many physicians and patient advocacy groups have made strides toward increasing awareness about the disease, as early diagnosis and treatment can help to manage complications and prevent progression of inflammation and fibrosis.