Sept 18 (Reuters) – Zealand Pharma received a positive opinion from the Committee for Medicinal Products for Human Use recommending approval of its drug candidate Zeydovio for the treatment of short bowel syndrome, the Danish company said on Friday.
The positive opinion marks the first major advancement in short bowel syndrome treatment in Europe in more than a decade, the drugmaker added.
• The long-acting GLP-2 analogue glepaglutide cut patients’ need for parenteral support in a late-stage trial, with 65.7% of patients achieving at least a 20% reduction versus 38.9% on placebo.
• One in seven patients on the twice-weekly dose came off the nutrition and fluid support entirely after 24 weeks of treatment, Zealand Pharma said.
• The company will now step up talks to find a global commercial partner responsible for the drug’s launch in Europe and the US, CEO Adam Steensberg said.
• The European Commission will now review the opinion, with a final decision on the drug’s marketing authorization expected within about 67 days.
• Zealand Pharma is enrolling patients in another late-stage trial to support a US New Drug Application for the drug.
(Reporting by Vera Dvorakova and Jesus Calero in Gdansk; Editing by Milla Nissi-Prussak)
