FDA Issues Complete Response Letter for Zealand Pharma’s Glepaglutide in Short Bowel Syndrome Treatment
FDA Rejection:
The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for Zealand Pharma's New Drug Application (NDA) for glepaglutide, a long-acting GLP-2 analog, intended for the treatment of adult patients with short bowel syndrome (SBS) with intestinal failure (IF) who are dependent on parenteral support24.
Reason for Rejection:
The FDA concluded that Zealand Pharma’s application did not meet the full requirements for substantial evidence to establish the efficacy and safety of the to-be-marketed dose of glepaglutide. The agency recommended an additional clinical trial to provide further evidence to confirm the efficacy and safety of glepaglutide at the proposed dose2.
Clinical Trials:
The submitted NDA included a single randomized, placebo-controlled Phase 3 registration trial, which showed significant and superior effects in reducing parenteral support requirements in patients with SBS-IF compared to placebo when administered twice weekly. However, once-weekly administration did not achieve statistical significance2.
Future Plans:
Zealand Pharma plans to continue dialogue with the FDA to align on the path toward obtaining regulatory approval in the U.S. and expects to proceed with its current plans for a European Marketing Authorization Application submission in 2025. The company also plans to initiate a single Phase 3 trial in 2025 to support marketing authorizations for glepaglutide in geographies outside the U.S. and the EU2.
Background:
Glepaglutide is a long-acting GLP-2 analog aimed at reducing or eliminating the need for parenteral support in people living with SBS. It has received orphan drug designation from the FDA for the treatment of SBS2.
Sources:
2. https://www.biospace.com/press-releases/u-s-food-and-drug-administration-issues-complete-response-letter-for-the-glepaglutide-new-drug-application-for-the-treatment-of-short-bowel-syndrome