Posted by Michael Wonder on 23 Dec 2023
Zealand Pharma submits new drug application to the US FDA for glepaglutide in short bowel syndrome
22 December 2023 - Zealand Pharma today announced the submission of a new drug application to the US FDA for glepaglutide, a long-acting GLP-2 analogue, for the treatment of adult patients with short bowel syndrome dependent on parenteral support.
The submission is based on the results from a pivotal Phase 3 trial (EASE-1), supported by interim results from two on-going long-term extension trials (EASE-2 and EASE-3), and a mechanistic trial (EASE-4).
