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Jump to Key Points Zeydovio (glepaglutide, Zealand Pharma A/S) has received a positive opinion from the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP), recommending it for marketing authorization in the EU for the treatment of short-bowel syndrome (SBS).
The therapy is indicated for adults with SBS who are clinically stable following a period of postsurgical intestinal adaptation. Treatment should be initiated under the supervision of a healthcare professional experienced in managing SBS.
What Is SBS?
SBS is a rare, chronic, and severe condition resulting from extensive surgical resection of the small intestine. The resulting loss of absorptive surface area leads to malabsorption of nutrients, fluids, and electrolytes, which can progress to intestinal failure.
Patients with severe SBS are unable to meet their nutritional and hydration needs through oral intake alone and become dependent on parenteral support delivered intravenously. Pharmacologic therapy aims to promote intestinal adaptation, strengthening the absorptive capacity of the remaining bowel, so that reliance on parenteral support can be reduced or eliminated.
- EMA CHMP positive opinion for glepaglutide in adult SBS.
- Indicated after postsurgical intestinal adaptation; start under SBS-experienced supervision.
- GLP-2 analog ↑ mucosal growth, blood flow; ↓ acid secretion, motility.
- Phase 3 EASE-1: 106 adults; 24 weeks; ↓ weekly parenteral support vs placebo.
- Common AEs: injection-site reactions, GI stoma issues, abdominal pain, distension, nausea, fluid overload, vomiting.
How the GLP-2 Analog Works
Glepaglutide is a long-acting analog of glucagon-like peptide 2 (GLP-2), a hormone with intestinotrophic properties. It increases intestinal and portal blood flow, inhibits gastric acid secretion, and slows intestinal motility. These effects promote structural growth of the intestinal mucosa, including increased mucosal thickness, intestinal epithelial height, and crypt depth.
Zeydovio will be supplied as a 10-mg solution for injection in a prefilled pen. It is administered subcutaneously.
Reducing Parenteral Support
Supporting evidence includes published results from the phase 3 EASE-1 trial, a randomized, placebo-controlled study in 106 adults with SBS who required parenteral support at least 3 days per week. At 24 weeks, twice-weekly glepaglutide 10 mg significantly reduced weekly parenteral support volume compared with placebo.
The CHMP describes the main benefit of Zeydovio as a greater reduction in weekly parenteral support volume with twice-weekly glepaglutide over 24 weeks compared with placebo.
Safety Profile
The most common adverse effects reported with glepaglutide include injection-site reactions, gastrointestinal stoma complications in patients with a stoma, abdominal pain, abdominal distension, nausea, fluid retention or overload, and vomiting.
Detailed recommendations for product use will be published in the Summary of Product Characteristics on the EMA website following official marketing authorization by the European Commission.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
