Cholangitis

Findings from a 2.5-year interim analysis from the ongoing phase 3 ASSURE study highlight seladelpar’s sustained efficacy and long-term safety for PBC.

The CRL is consistent with the outcome of a September Gastrointestinal Drugs Advisory Committee meeting.

Phase 3, 3b, and 4 clinical trials will provide long-term insight into the use of elafibranor in different PBC patient populations and real-world settings.

Open-label, interim data from ASSURE shows positive effect and tolerability with once-daily seladelpar in patients with primary biliary cholangitis and compensated cirrhosis.

Data from ACG 2024 show only 1 in 12 patients eligible for second-line PBC therapy are actually doing receiving it—and it may take up to a year to initiate.

The FDA has extended its review of the sNDA, delaying the previous October 15, 2024, PDUFA date, without providing a new anticipated action date.

The designation was granted to Mirum Pharmaceuticals based on a positive interim analysis of the phase 2b VANTAGE study of volixibat.

Positive 120-day data from the phase 2a study of CNP-104 in PBC highlight its efficacy across multiple immunological and clinical measurements

With HepQuant DuO and SHUNT tests, investigators could categorize patients with sclerosing cholangitis into low, moderate, and high disease severity subgroups.

Reau explains the importance of second- and third-line treatment in PBC and the potential implications of no longer having OCA after a negative FDA advisory committee meeting.

Moser reviews ongoing unmet needs in PBC and how the addition of 2 new second-line treatment options has changed the treatment landscape.

Mathew reviews common reasons for diagnostic delays in PBC, emphasizing the importance of timely identification and prompt treatment for improving patient outcomes.

The decision to revoke the conditional marketing authorization is based on a June 2024 CHMP recommendation from the EMA suggesting the benefits of Ocaliva do not outweigh its risks.

Endoscopic ultrasound-guided rendezvous technique and precut sphincterotomy had similar technical success, and failure with one method could be successfully cannulated with the other.

Kumar explains what is known about the use of PPAR agonists in primary biliary cholangitis and the significance of the recent FDA accelerated approvals of elafibranor and seladelpar.

In this video segment, Reau, Trivedi, and Hirschfield discuss pipeline developments and other advances in primary biliary cholangitis they are most looking forward to.

In this video segment, Reau, Trivedi, and Hirschfield discuss how the emergence of second-generation PPAR agonists like seladelpar and elafibranor impact PBC management.

In this video segment, Reau, Trivedi, and Hirschfield discuss how treatment sequencing in PBC has evolved over time with the emergence of new second-line therapies and considerations for determining sequencing.

In this video segment, Reau, Trivedi, and Hirschfield discuss the EMA opinion on obeticholic acid and its impact on discussions about second-line therapies amid the influx of new treatment options available for patients.

In this video segment, Reau, Trivedi, and Hirschfield discuss the availability of new second-line treatment options and their role in PBC management compared to traditional therapies like UDCA and OCA.

In this video segment, Reau, Trivedi, and Hirschfield discuss recent shifts in treatment goals for patients with PBC and a new focus on timely intervention with second-line options.

The accelerated approval is based on phase 3 data demonstrating seladelpar’s impact on ALP reduction and is contingent upon verification and description of clinical benefit in confirmatory trial(s).

Study finds elevated HAMD-17 scores in PBC patients predict cirrhosis risk, with depressive symptoms linked to higher liver enzyme levels and worse UDCA response.

This July 2024 month in review highlights pipeline movement in hepatology as well as research about novel diagnostic/prognostic approaches and factors impacting hepatic health outcomes.

Positive topline results from the phase 2 SPRING trial highlight CM-101’s anti-fibrotic, anti-inflammatory, and anti-cholestatic effects in primary sclerosing cholangitis.