Gastroenterology Year in Review: 2024

HCPLive Gastroenterology Year in Review: 2024

2024 has been a landmark period for gastroenterology, defined by groundbreaking FDA approvals across a multitude of disease states and pivotal updates in clinical practice guidance from the American Gastroenterological Association (AGA).

The field saw the introduction of several new therapies for ulcerative colitis (UC), Crohn’s disease (CD), eosinophilic esophagitis (EoE), and gastroesophageal reflux disease (GERD), as well as multiple novel noninvasive colorectal cancer (CRC) screening tests. In addition to expanding GI treatments and tests, 2024 also saw the publication of new guidance from the AGA about the use of fecal microbiota-based therapies for gastrointestinal disease and the diagnosis and management of cyclic vomiting syndrome (CVS).

Collectively, these developments underscore the momentum in the field, as gastroenterologists leverage cutting-edge science to improve patient outcomes in both inflammatory and neoplastic diseases.

Check out HCPLive’s coverage of the top gastroenterological news from 2024 in this gastroenterology year in review!

Dupilumab's Role in Managing Pediatric EoE, with Evan Dellon, MD, MPH

On January 25, 2024, the FDA approved dupilumab (Dupixent) for the treatment of eosinophilic esophagitis (EoE) in pediatric patients 1-11 years of age weighing ≥ 15 kg, making it the first and only FDA-approved medicine specifically indicated for this patient population.

The approval expanded the previous FDA decision for dupilumab in adult and pediatric patients ≥ 12 years of age weighing ≥ 40 kg in May of 2022, when the fully human monoclonal antibody became the first and only medicine specifically indicated to treat EoE in the United States.

Related: Long Time Coming: Pediatric Gastroenterologists React to New Dupilumab EoE Approval

FDA Approves Budesonide Oral Suspension (Eohilia) for Eosinophilic Esophagitis

The FDA approved budesonide oral suspension (Eohilia) for patients ≥ 11 years of age with EoE, on February 12, 2024, making it the first and only FDA-approved oral therapy for this patient population. The approval was based on efficacy and safety data from a pair of multicenter, randomized, double-blind, parallel-group, placebo-controlled 12-week studies in patients ages 11-56 years and 11-42 years, respectively, with EoE.

AGA Supports Fecal Microbiota-Based Therapies for C Diff in New Guideline

In 2024, the American Gastroenterological Association (AGA) released the first comprehensive evidence-based guideline on the use of fecal microbiota-based therapies for gastrointestinal disease. The guideline recommends the use of FMT-based therapy in patients with recurrent CDI at high risk of recurrence following standard-of-care antibiotics and in hospitalized patients with severe CDI after standard-of-care antibiotics if there is no improvement. Of note, the AGA does not recommend FMT therapies for inflammatory bowel disease (IBD) or irritable bowel syndrome (IBS).

Related: Experts’ Perspectives: AGA Recommends FMT for C Diff

Cyclic Vomiting Syndrome Clinical Practice Update Guides Diagnosis, Management

The AGA also released clinical guidance to help clinicians and patients recognize the signs and symptoms of CVS in 2024. The clinical practice update reviews the available evidence and provides expert advice regarding the diagnosis and management of CVS, a highly prevalent yet poorly recognized condition that is often underdiagnosed and subsequently undertreated.

Related: David Levinthal, MD, PhD: Cyclic Vomiting Syndrome Diagnosis, Management

Vonoprazan (Voquezna) Receives FDA Approval for Heartburn Associated with Non-Erosive GERD

The FDA approved vonoprazan (Voquezna) as a daily treatment for heartburn associated with non-erosive GERD in adult patients on July 18, 2024, based on data from the phase 3 PHALCON-NERD-301 study evaluating the efficacy and safety of vonoprazan as a daily treatment in adult patients with non-erosive GERD, also known as NERD.

Related: Matthew Hoscheit, MD: Expanding the GERD Treatment Armamentarium with Vonoprazan

Subcutaneous Vedolizumab Approved for Moderate-to-Severe Crohn Disease

The FDA approved subcutaneous vedolizumab (Entyvio) for the treatment of moderately to severely active CD based on data from the VISIBLE 2 trial, indicating the agent for maintenance therapy in adults with moderately to severely active CD after induction therapy with intravenous vedolizumab. Announced on April 22, 2024, the approval marked the third approval for vedolizumab and the second over the span of 7 months.

FDA Approves Risankizumab (Skyrizi) for Ulcerative Colitis

The FDA approved risankizumab-rzaa (Skyrizi) for adults with moderately to severely active UC, making it the first interleukin (IL)-23 specific inhibitor approved for both moderate to severe UC and moderate to severe CD. The decision was supported by data from a pair of phase 3 clinical trials showing that clinical remission, the primary endpoint in both the induction and maintenance studies, was achieved along with endoscopic improvement, a key secondary endpoint.

FDA Approves Guselkumab (Tremfya) for Ulcerative Colitis

In a second notable FDA decision for UC in 2024, the FDA approved guselkumab (Tremfya) for the treatment of adults with moderately to severely active UC. The decision was based on data from the ongoing phase 2b/3 QUASAR study demonstrating guselkumab’s ability to induce clinical and endoscopic remission in adult patients with moderately to severely active UC who experienced an inadequate response or who demonstrate intolerance to conventional therapy, other biologics and/or JAK inhibitors. Of note, the approval makes guselkumab the first and only approved fully-human, dual-acting monoclonal antibody that blocks interleukin (IL)-23 while also binding to CD64, a receptor on cells that produce IL-23.

FDA Approves ColoSense, a Noninvasive mt-sRNA Test, for Adults 45 or Older

2024 was a busy year for colorectal cancer screening, beginning with the FDA’s May 6, 2024, approval of ColoSense, a noninvasive multi-target stool RNA (mt-sRNA) colorectal cancer screening test, for use as a screening test in adult patients aged 45 years or older considered to be at average risk for developing CRC.

FDA Approves First Blood Test for Primary Colorectal Cancer Screening

In July, the FDA approved Guardant Health’s Shield blood test for CRC screening in adults 45 years of age and older at average risk for the disease. The decision made Shield the first blood test to be approved by the FDA as a primary screening option for CRC, and it was the first blood test for CRC screening to meet the requirements for Medicare coverage.

Related: William Grady, MD: Improving Colorectal Cancer Screening Compliance with Patient Choice

FDA Approves Exact Sciences’ Cologuard Plus Test for Colorectal Cancer Screening

The FDA also approved Exact Sciences’ Cologuard Plus test, the company’s next-generation multitarget stool DNA test, for adults ≥ 45 years of age at average risk for CRC.

The approval was based on findings from the BLUE-C study, one of the largest prospective, head-to-head studies ever conducted in CRC screening. Among a subset of nearly 19,000 average-risk participants, the Cologuard Plus test demonstrated 95% overall cancer sensitivity and 43% sensitivity for advanced precancerous lesions at 94% specificity with no findings on colonoscopy.