Danish biotechnology company Zealand Pharma A/S (Nasdaq: ZEAL) announced on Friday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending marketing authorisation for Zeydovio (glepaglutide), a long-acting, next-generation GLP-2 analogue, for the treatment of adults with short bowel syndrome (SBS).

The positive opinion is based on data from the pivotal Phase 3 EASE-1 trial, in which twice-weekly glepaglutide demonstrated statistically significant and superior reductions in parenteral support requirements in SBS patients with intestinal failure (IF) compared to placebo. These data were supported by interim results from the EASE-2 and EASE-3 trials, the long-term extension trials of up to two years, and results from a mechanistic trial (EASE-4) providing evidence of glepaglutide's pharmacodynamic effects in improving intestinal absorption. In the clinical trials to date, glepaglutide treatment appeared safe and well tolerated.

Results from the EASE-2 and EASE-3 trials, which confirmed the long-term efficacy and safety of glepagutide, are expected to be presented at scientific meetings in 2027.

The CHMP's opinion will now be reviewed by the European Commission, with a final decision on marketing authorisation expected within approximately 67 days. Subject to European Commission approval, the marketing authorisation would be valid in all member states of the European Union, as well as Iceland, Liechtenstein, and Norway.

Zealand Pharma said that it is actively engaging in partnership discussions for the future global commercialisation of glepaglutide for SBS.