Primary Biliary Cholangitis
Cour Pharmaceuticals snags orphan drug designation for CNP-104 for the treatment of PBC
The FDA has granted Cour Pharmaceuticals orphan drug designation for CNP-104, a biodegradable nanoparticle in development for the treatment of primary biliary cholangitis, the company announced in a press release.
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.
Livdelzi reduces cholestatic, liver injury markers in patients with PBC and cirrhosis
SAN DIEGO — Livdelzi appeared safe and well-tolerated and reduced markers of cholestasis and liver injury in patients with primary biliary cholangitis, including those with compensated cirrhosis, according to a presenter.
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.
ELATIVE: Iqirvo ‘effective, well-tolerated treatment option’ for advanced-stage PBC
PHILADELPHIA — Iqirvo demonstrated significant biochemical response and alkaline phosphatase normalization in patients with both early- and advanced-stage primary biliary cholangitis, according to late-breaking data presented here.
Drug rivals face off in PBC after FDA hands down 2 new approvals, 1 advisory snub
The long-stagnant primary biliary cholangitis drug market has seen renewed attention in the past 3 months with the addition of two FDA-approved therapy options as well as a costly ruling from an FDA advisory committee.