Gastroenterology Month in Review: February 2025

February delivered a robust slate of advancements in gastroenterology, characterized by notable drug developments and pivotal clinical research.

The month saw the launch of a new ulcerative colitis (UC) drug and FDA Fast Track Designation for a potential familial adenomatous polyposis (FAP) therapy as well as research about COVID-19’s link to GI symptoms and disorders; the association between adenomas and colorectal cancer; changing rates of alcohol-associated pancreatitis; and mirikizumab’s long-term safety and efficacy in patients with Crohn’s disease (CD).

Check out this February 2025 gastroenterology month in review for a recap of HCPLive’s coverage of the top GI news and research from the past few weeks:

GI FDA News

eRapa Receives FDA Fast Track Designation for Familial Adenomatous Polyposis

On February 10, the US Food and Drug Administration granted Fast Track Designation to Biodexa Pharmaceuticals’ eRapa, a proprietary encapsulated form of rapamycin being developed for the treatment of FAP.

Currently, the only treatment option for FAP is surgical resection of the colon and/or rectum. Left untreated, FAP universally leads to colorectal cancer.

Amneal Launches Mesalamine for Ulcerative Colitis, Receives Lenalidomide FDA Approval

On February 19, Amneal Pharmaceuticals announced the launch of mesalamine 800 mg delayed-release tablets, an aminosalicylate indicated for the treatment of adult patients with moderately active UC. In addition to the launch of the 5-aminosalicylic acid (5-ASA) referencing ASACOL HD®, the FDA also approved Amneal’s Abbreviated New Drug Application for lenalidomide capsules in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg doses for the treatment of blood cancers.

Recent Gastro Research

COVID-19 Linked to Greater Risk of GI Tract Symptoms, Disorders in Children

Findings from this study suggest COVID-19 is associated with an increased risk of GI tract symptoms and diseases during the postacute and chronic phases of infection in pediatric patients. Results highlight a significant association between documented SARS-CoV-2 infection and increased risks of abdominal pain, bloating, constipation, and gastroesophageal reflux disease (GERD) extending into the chronic phase.

Adenomas Linked to Greater Risk of Colorectal Cancer, All-Cause Mortality

Recent research is sounding the alarm on a heightened risk of colorectal cancer in patients with both nonadvanced and advanced adenomas detected during colonoscopy.

In the study, individuals with adenomas at colonoscopy, regardless of whether or not they were advanced, were at a greater risk of developing colorectal cancer than those with no adenomas. Additionally, findings showed participants with advanced adenomas were at increased risk of both colorectal cancer mortality and all-cause mortality.

Alcohol-Associated Pancreatitis Rates Increasing in Adolescents, Young Adults

Findings from this study suggest gastrointestinal complications from alcohol are increasing in adolescents and young adults at greater rates than in other organ systems. Specifically, pancreas-related complications from alcohol were more frequent than liver-related complications, and while male patients were most affected by pancreatitis and alcohol-associated liver disease, female patients experienced greater changes in the rates of both than their male counterparts.

New Mirikizumab Data for Crohn’s Disease

VIVID-2: Mirikizumab (Omvoh) Shows Long-Term Efficacy for Crohn’s Disease

In the VIVID-2 open-label extension study of mirikizumab-mrkz (Omvoh) in patients with moderately to severely active CD, the majority of patients receiving 2 years of continuous treatment with mirikizumab achieved long-term clinical and endoscopic outcomes, including those with previous biologic failure.

Related: Long-Term VIVID-2 Data for Mirikizumab in Crohn’s Disease, with Edward Barnes, MD, MPH