Obeticholic Acid

An FDA advisory committee voted against approval for obeticholic acid in pre-cirrhotic patients with liver fibrosis due to nonalcoholic steatohepatitis, citing “concerning” benefit-risk profile.

The FDA granted Intercept Pharmaceuticals orphan drug designation for the fixed-dose combination of obeticholic acid and bezafibrate intended for treatment of patients with primary biliary cholangitis.

Obeticholic acid failed to demonstrate superiority to placebo for improving fibrosis in patients with compensated cirrhosis due to nonalcoholic steatohepatitis in a phase 3 trial, according to an Intercept Pharmaceuticals press release.

Patients who received obeticholic acid for primary biliary cholangitis experienced greater transplant-free survival compared with external control patients, according to research published in Gastroenterology.

Providers should closely monitor people with diabetes and other high-risk adults for nonalcoholic fatty liver disease and consider multiple noninvasive tests to detect the presence of advanced fibrosis, according to a speaker.

In a video exclusive, Gideon Hirschfield, PhD, FRCP, of the University of Toronto, reported the potential of obeticholic acid for improving transplant-free survival among patients with primary biliary cholangitis.

Early and sustained improvements in non-invasive markers of nonalcoholic steatohepatitis and advanced fibrosis were observed in patients treated with obeticholic acid, according to research presented at The Digital International Liver Congress.

The FDA issued a complete response letter for the new drug application for obeticholic acid for treatment of fibrosis due to nonalcoholic steatohepatitis, according to a press release from Intercept Pharmaceutical Inc.

BOSTON — In this exclusive video from The Liver Meeting 2019, Zobair M. Younossi, MD, chairman of the department of medicine at Inova Fairfax Hospital in Virginia, provides an overview of patient reported outcomes from several studies of emerging nonalcoholic fatty liver disease and nonalcoholic steatohepatitis therapies.

The FDA accepted the first new drug application for the treatment of liver fibrosis due to nonalcoholic steatohepatitis; Intercept announced that obeticholic acid, already approved for the treatment of primary biliary cholangitis under the brand Ocaliva, has a PDUFA date of March 26, 2020.