Gastroenterology Month in Review: December 2024

Despite 2024 winding to a close, December was a busy month for the field of gastroenterology. Ending the year with just as much vigor as it displayed in months prior, the home stretch of 2024 saw multiple regulatory and pipeline GI updates, the publication of a feature about the state of endoscopic procedures with the evergrowing popularity of GLP-1 RAs, and new irritable bowel syndrome (IBS) research.

Check out this December 2024 month in review for HCPLive’s coverage of the top GI news and research from the month!

December GI FDA News, Pipeline Updates

J&J Submits sBLA for Golimumab (Simponi) for Pediatric Ulcerative Colitis

On December 18, 2024, Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the FDA seeking expanded approval of golimumab (Simponi) for the treatment of children ≥ 2 years of age with moderately to severely active ulcerative colitis (UC).

The sBLA for golimumab, which is currently approved for the treatment of adults with moderately to severely active UC, is supported by data from the Program of Ulcerative Colitis Research Studies Utilizing an Investigational Treatment (PURSUIT) program, including multi-center, open-label studies evaluating the efficacy, safety, and pharmacokinetics of subcutaneously administered golimumab for the treatment of pediatric UC.

FDA Issues CRL to Glepaglutide for Short Bowel Syndrome, Cites Insufficient Evidence

Zealand Pharma’s New Drug Application for glepaglutide for the treatment of adult patients with short bowel syndrome (SBS) dependent on parenteral support (PS) was met with a Complete Response Letter (CRL) from the FDA on December 19, 2024. The CRL stated that the application did not meet the full requirements for substantial evidence to establish the efficacy and safety of the to-be-marketed dose of glepaglutide. As a result, the FDA recommends Zealand Pharma conduct an additional clinical trial to provide further evidence to confirm the efficacy and safety of glepaglutide at this dose.

Duvakitug Meets Primary Endpoints in Phase 2b RELIEVE UCCD Study for IBD

On December 17, 2024, Teva Pharmaceuticals and Sanofi announced positive data from the phase 2b RELIEVE UCCD study of duvakitug in patients with UC and Crohn disease (CD) showing the study met its primary endpoints for clinical remission and endoscopic response in patients with moderate to severe inflammatory bowel disease (IBD).

Of note, the primary endpoint results in both UC and CD for the high dose arm represent the greatest achieved with any tumor necrosis factor (TNF)-like ligand 1A (TL1A) monoclonal antibody. Pending regulatory discussions, Sanofi and Teva plan to initiate phase 3 development in IBD.

Gastro in HCPLive’s This Year in Medicine

Endoscopy in the Age of GLP-1 RAs: 2024 Sees New Risk-Based Perioperative Guidance

As part of HCPLive’s This Year in Medicine series, this feature takes a closer look at the rise of GLP-1 RAs and the impact of their use in the context of endoscopic procedures due to their effects on gastric motility. In this article, 4 experts weigh in on the state of GI care in the age of GLP-1 RAs and discuss the implications of past and present clinical guidance regarding whether or not these medications need to be held before upper endoscopy.

New IBS Research

Autonomic Modulation May Benefit Patients with Constipation-Predominant IBS

Findings from this study suggest the potential value of modulating autonomic outflow in patients with constipation-predominant IBS (IBS-C), highlighting the presence of systemic and local autonomic imbalance in this patient population. Coined by investigators as the first to assess both systemic autonomic function and localized intestinal blood flow dynamics in patients with IBS while also accounting for predominant bowel habits and controlling for psychological comorbidity, the study points to a greater fasting superior mesenteric artery end-diastolic velocity (SMA-EDV) and a lower pulse transit time (PTT) in patients with IBS-C.

Lower Diet Diversity, Quality Linked to More Severe IBS Symptoms

Poor diet diversity and quality may be associated with more severe IBS symptoms, according to findings from this study. Relative to controls from the general population, individuals with IBS exhibited notable differences in dietary patterns, with poorer dietary habits linked to greater IBS symptom severity.

Christine Frissora, MD: Vibrant System’s Role in Chronic Idiopathic Constipation Care

New research suggests the Vibrant System may be the most cost-effective option for chronic idiopathic constipation (CIC) management, highlighting reduced costs and improved quality-adjusted life years versus linaclotide. In addition to lower costs and improved quality of life, findings showed patients on the Vibrant System experienced fewer side effects frequently observed with linaclotide and linked to treatment discontinuation, including diarrhea, abdominal pain, and abdominal distension.