Healio

VIDEO: ‘Encouraging’ safety data on Livdelzi in primary biliary cholangitis, cirrhosis

Please provide your email address to receive an email when new articles are posted on . PHILADELPHIA — In this video, Nancy S. Reau, MD, FAASLD, AGAF, highlights a presentation at the ACG Annual ...
Healio

Livdelzi reduces cholestatic, liver injury markers in patients with PBC and cirrhosis

Please provide your email address to receive an email when new articles are posted on . Patients with PBC and cirrhosis treated with seladelpar exhibited greater reductions in ALP, GGT and ALT at 12 ...
Medscape

Antinuclear Antibodies as Ancillary Markers in Primary Biliary Cirrhosis

Expert Rev Mol Diagn. 2012;12(1):65-74. The NE is composed of three morphologically and functionally interconnected structures: a double bilayer nuclear membrane enclosing the perinuclear space; the ...
EurekAlert!

Guidelines on the diagnosis and management of primary biliary cholangitis

Primary biliary cholangitis (PBC), previously referred to as primary biliary cirrhosis, is an autoimmune disorder characterized by intrahepatic cholestasis. While the precise etiology and pathogenesis ...
MedPage Today

Primary Biliary Cholangitis: Does Inflammation Lower Quality of Life?

—A Danish cohort study found higher levels of the inflammation marker SCD163 were associated with lower quality of life in primary biliary cholangitis patients. Patients with primary biliary ...
Monthly Prescribing Reference

ASSURE: Seladelpar Beneficial for Patients With Primary Biliary Cholangitis

Initial data from ASSURE showed 70% of the 148 patients who completed 12 months of treatment with seladelpar achieved the composite response endpoint. Seladelpar was associated with improvement in ...
MedPage Today

Simplifying Risk Stratification in Primary Biliary Cholangitis

—A large international cohort study of patients with primary biliary cholangitis recently demonstrated that the most recent liver stiffness measurement is the single strongest, independent predictor ...
Business Wire

Investigational Seladelpar Demonstrates Significant Improvements in Liver Disease Progression and Reduced Itching in Primary Biliary Cholangitis

FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD), following the recent acquisition of CymaBay Therapeutics, Inc., today announced interim results from the ongoing ASSURE ...
Medscape

EMA Backs Oral Drug for Primary Biliary Cholangitis

The European Medicines Agency (EMA) has recommended that a conditional marketing authorization should be granted for Iqirvo (elafibranor; Ipsen Pharma) for treating primary biliary cholangitis (PBC).
Managed Healthcare Executive

FDA approves treatment for debilitating itch in rare liver disease

Lynavoy is used to treat cholestatic pruritus, an extreme itch that affects almost 90% of patients with primary biliary cholangitis.
Business Wire

Gilead’s Livdelzi (Seladelpar) Granted Accelerated Approval for Primary Biliary Cholangitis by U.S. FDA

FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Livdelzi ® (seladelpar) ...
Nasdaq

Gilead’s Livdelzi (Seladelpar) Granted Accelerated Approval for Primary Biliary Cholangitis by U.S. FDA

The accelerated approval was based primarily on data from the pivotal placebo-controlled Phase 3 RESPONSE study. In the study, 62% of participants taking Livdelzi achieved the primary endpoint of ...