Zealand Pharma has received a major regulatory boost for Zeydovio (glepaglutide), with Europe’s medicines regulator recommending marketing authorization for the treatment of adults with short bowel syndrome (SBS).

 

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion on Zeydovio, a long-acting, next-generation GLP-2 analog developed to treat patients with SBS.

 

The recommendation marks a significant step toward potential approval of the therapy across the European Union.

 

"The positive opinion for Zeydovio is the first major advancement in short bowel syndrome treatment in Europe in more than a decade. Those living with short bowel syndrome face significant daily burdens and are susceptible to significant health risks from parenteral support, and every day free from it can be life changing. 

 

"In the Phase 3 trials, Zeydovio significantly reduced parenteral support volume, reducing the number of days required for many patients and eliminating the need for it entirely in others,” said David Kendall, Chief Medical Officer of Zealand Pharma. "Offering simple dosing twice weekly via a ready-to-use autoinjector, Zeydovio holds potential as a transformative therapy for SBS that could meaningfully ease the burden of disease management for thousands of patients.”

 

The positive CHMP opinion is supported by results from the pivotal Phase 3 EASE-1 trial. In the study, twice-weekly glepaglutide produced statistically significant and superior reductions in the need for parenteral support among SBS patients with intestinal failure compared with placebo.

 

Additional evidence came from interim results from the EASE-2 and EASE-3 long-term extension trials, which follow patients for up to two years, as well as the mechanistic EASE-4 trial. The latter provided evidence of glepaglutide’s pharmacodynamic effects in improving intestinal absorption.

 

Across clinical trials conducted to date, glepaglutide appeared safe and well tolerated. Full results from EASE-2 and EASE-3, which confirmed the therapy’s long-term efficacy and safety, are expected to be presented at scientific meetings in 2027.

 

The CHMP recommendation now moves to the European Commission for review. A final decision on the Marketing Authorization Application is expected within approximately 67 days.

 

If approved, the authorization would cover all European Union member states, as well as Iceland, Liechtenstein and Norway.