Zealand Pharma on Wednesday won endorsement from the European Medicines Agency's Committee for Medicinal Products for Human Use to approve Zeydovio (glepaglutide) for treating adults with short bowel syndrome.
The drug, a long-acting GLP-2 analog given twice-weekly via autoinjector, would be marketed across all EU member states as well as Iceland, Liechtenstein and Norway if the European Commission gives its final approval.
The positive opinion was based on data from the phase 3 EASE-1 trial, which enrolled 106 patients with short bowel syndrome and intestinal failure who relied on parenteral support at least three days per week. After 24 weeks, patients on the twice-weekly regimen reduced their parenteral support volume by 5.13 liters weekly versus 2.85 liters for the placebo group. A 20 percent reduction in weekly support volume was achieved by 65.7 percent of treated patients compared with 38.9 percent on placebo. Five patients — 14 percent of the treatment group — were completely weaned off parenteral support, with none doing so on placebo.
The European Commission is expected to review the CHMP opinion and issue a final decision within approximately 67 days. If granted, the drug would be among the first therapies targeting short bowel syndrome, a rare chronic condition caused by reduced intestinal function that leaves many patients dependent on intravenous nutrition.
Zealand Pharma has also received orphan drug designation from the U.S. Food and Drug Administration for glepaglutide in the same indication. The company is currently running the phase 3 EASE-5 trial with ongoing patient recruitment in the United States to support a regulatory submission there.
The company said it is engaged in partnership discussions aimed at the global commercialization of Zeydovio.
