ZEALAND PHARMA AS

Zealand Pharma announced the FDA issued a complete response letter for its NDA for glepaglutide, a GLP-2 analog for short bowel syndrome with intestinal failure. The FDA recommended an additional trial for efficacy and safety confirmation. Zealand Pharma remains committed to regulatory approval and plans a European MAA submission in 2025.

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Zealand Pharma's drug candidate for short bowel syndrome was not approved by the FDA.

The FDA issued a Complete Response Letter to Zealand Pharma's glepaglutide for short bowel syndrome, stating the NDA lacked substantial evidence for efficacy and safety. Zealand Pharma plans a phase 3 trial in 2025 to support marketing outside the US and EU, with confidence in glepaglutide's efficacy and safety based on phase 3 EASE program data.

Zealand Pharma's new drug application for glepaglutide, a proposed short bowel syndrome treatment, did not meet full FDA requirements. Zealand remains confident in the drug's efficacy and safety and will continue dialogue with the FDA. The company also plans to submit a European Marketing Authorization Application next year.

The FDA issued a Complete Response Letter for Zealand Pharma's glepaglutide NDA, stating the application lacked substantial evidence for efficacy and safety. Zealand Pharma plans to continue dialogue with the FDA and expects to submit a European Marketing Authorization Application in 2025.

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