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Zealand Pharma receives positive CHMP opinion for Zeydovio™ (glepaglutide) for the treatment of short bowel syndrome

ZEAL
  • The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending marketing authorization for Zeydovio™ (glepaglutide) to treat adults with short bowel syndrome (SBS).
  • This recommendation marks the first major advancement in SBS treatment in Europe in over a decade.
  • In the pivotal Phase 3 EASE-1 trial, two-thirds of patients treated with glepaglutide achieved a clinical response defined as at least a 20% reduction in weekly parenteral support volume after 24 weeks.
  • One in seven patients treated with glepaglutide was weaned off parenteral support entirely within 24 weeks.
  • Zeydovio is a long-acting GLP-2 analog designed for twice-weekly subcutaneous administration via a ready-to-use autoinjector.
  • The CHMP opinion is based on data from the EASE-1 trial, interim results from EASE-2 and EASE-3 trials, long-term extension data, and mechanistic findings from the EASE-4 trial.
  • The European Commission will review the CHMP opinion, with a final decision expected within approximately 67 days of this announcement.
  • Subject to European Commission approval, the marketing authorization would be valid across all EU member states, Iceland, Liechtenstein, and Norway.
  • Zealand Pharma is actively recruiting for the Phase 3 EASE-5 trial to support a U.S. New Drug Application (NDA).
  • The company is engaging in partnership discussions for the global commercialization of glepaglutide.
  • Results from the EASE-2 and EASE-3 trials confirming long-term efficacy and safety are expected to be presented at scientific meetings in 2027.
  • The U.S. FDA has granted orphan drug designation for glepaglutide for the treatment of SBS.
  • Glepaglutide treatment appeared safe and well tolerated across all clinical trials to date.