GI Advances: FDA Approvals, Novel Research Shape Gastroenterology in Early 2025
Key Insights
The FDA approved mirikizumab (Omvoh) for Crohn's disease (search), marking its second approval in IBD after ulcerative colitis (search), based on positive Phase 3 trial results.
A tentative FDA approval was granted for a generic version of rifaximin for IBS-D, offering a potential cost-effective alternative pending the resolution of ongoing litigation.
Ironwood initiated a rolling NDA submission for apraglutide, aiming to address short bowel syndrome (search) by reducing dependence on parenteral support.
The field of gastroenterology is off to a dynamic start in 2025, marked by significant regulatory approvals and groundbreaking research poised to reshape treatment paradigms for various gastrointestinal conditions. Here’s a look at the key developments.
Mirikizumab Approved for Crohn's Disease
On January 15, 2025, the FDA approved mirikizumab (Omvoh), developed by Lilly (search), for the treatment of adults with moderately to severely active Crohn's disease (search) (CD). This approval follows positive outcomes from the Phase 3 VIVID-1 study and marks the second indication for mirikizumab in inflammatory bowel disease (search) (IBD), having previously been approved for ulcerative colitis (search) (UC). Mirikizumab functions as an interleukin-23p19 (search) antagonist.
Generic Rifaximin Receives Tentative Approval for IBS-D
Amneal Pharmaceuticals secured tentative FDA approval on January 23, 2025, for its generic version of rifaximin 550 mg oral tablets, referencing Bausch Health’s Xifaxan, indicated for treating adults with irritable bowel syndrome (search) with diarrhea (IBS-D). The approval remains tentative due to ongoing litigation surrounding the product.
Rolling NDA Submission for Apraglutide in Short Bowel Syndrome
Ironwood Pharmaceuticals has initiated a rolling New Drug Application (NDA) submission for apraglutide, targeting patients with short bowel syndrome (search) (SBS) who are dependent on parenteral support. The submission includes data from the open-label extension study, STARS Extend, which demonstrated an increased number of patients achieving enteral autonomy over time with apraglutide. The NDA encompasses both efficacy and tolerability data from the STARS trial.
FMT Shows Promise in Type 1 Diabetes and Gastroenteropathy
New research highlights the potential of fecal microbiota transplantation (search) (FMT) in treating patients with type 1 diabetes (search) and gastroenteropathy. A pilot trial demonstrated significant improvements in gastrointestinal symptoms and overall quality of life. According to lead investigator Dr. Katrine Lundby Høyer from Aarhus University Hospital, "The patients experienced a significant improvement in their quality of life and symptoms, far beyond what we observed with placebo. This is the first time FMT has been tested specifically in this patient group with placebo as a control. The results are very promising."
Golimumab sBLA Submission for Pediatric Ulcerative Colitis
Johnson & Johnson submitted 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 (search) (UC) on December 18, 2024. The sBLA is supported by data from the PURSUIT program, evaluating the efficacy, safety, and pharmacokinetics of subcutaneously administered golimumab for the treatment of pediatric UC.
Glepaglutide Receives Complete Response Letter
Zealand Pharma’s New Drug Application for glepaglutide for the treatment of adult patients with short bowel syndrome (search) (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 Phase 2b Results in Ulcerative Colitis and Crohn's Disease
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 (search) (IBD) on December 17, 2024. Pending regulatory discussions, Sanofi and Teva plan to initiate phase 3 development in IBD.