Obeticholic Acid
Ocaliva down but not out: A timeline of FDA troubles for a once-promising PBC contender
Eight years ago, Ocaliva was a prospective lifesaver for patients with primary biliary cholangitis who failed to adequately respond to first-line ursodeoxycholic acid. However, the once-promising drug now finds itself struggling to deliver.
FDA: Ocaliva still linked to ‘serious liver injury’ in PBC, even without cirrhosis
The FDA has issued a safety alert warning that obeticholic acid carries an increased risk for “serious liver injury” among patients with primary biliary cholangitis, even those without advanced cirrhosis.
Patients with PBC who failed with obeticholic acid may still achieve ‘some benefit’
SAN DIEGO — Patients with primary biliary cholangitis who were incomplete responders to obeticholic acid may still demonstrate improvement in inflammatory markers and fibrosis scores, according to research presented at The Liver Meeting.
VIDEO: ‘Encouraging’ safety data on Livdelzi in primary biliary cholangitis, cirrhosis
PHILADELPHIA — In this video, Nancy S. Reau, MD, FAASLD, AGAF, highlights a presentation at the ACG Annual Scientific Meeting investigating the use of Livdelzi in patients with primary biliary cholangitis and cirrhosis.
FDA denies Ocaliva full approval in primary biliary cholangitis; safety data still in play
The FDA issued a complete response letter to Intercept Pharmaceuticals indicating it cannot grant full approval to the company’s supplemental new drug application for Ocaliva as a treatment for primary biliary cholangitis.
The leading edge: New therapies redefine PBC treatment landscape
Recent advancements have been made in the treatment of primary biliary cholangitis, particularly for patients who do not respond adequately to first-line treatment.
Q&A: ‘Make them explain’: How a patient’s self-advocacy finally led to a PBC diagnosis
When Tiffany McLellan was 18 years old, she was diagnosed with an ulcer in her digestive tract. She found relief with antacids for almost 2 years, but after her son was born, she started experiencing digestive issues and pain again.
Q&A: Unraveling the gut microbiome’s role in autoimmune biliary diseases
In this exclusive Healio interview, Gideon Hirschfield, PhD, MB Bchir, the Lily and Terry Horner Chair in Autoimmune Liver Disease at the University of Toronto, discusses the latest insights into the gut microbiome’s role as a key player in disease development and progression.
Intercept pivots away from NASH following second FDA rejection for obeticholic acid
The FDA issued a complete response letter to Intercept indicating it cannot approve the company’s new drug application for obeticholic acid as a treatment for pre-cirrhotic liver fibrosis due to nonalcoholic steatohepatitis.
Intercept ‘disappointed’ after FDA setback for top NASH contender; stock drops 16%
Intercept Pharmaceuticals saw a 16% drop in its stock value after an FDA advisory committee declined to approve obeticholic acid in pre-cirrhotic patients with liver fibrosis due to nonalcoholic steatohepatitis.