Zealand Pharma Fails to Get FDA Approval for Short Bowel Syndrome Drug

MT Newswires Live12-20

Zealand Pharma (ZEAL) said Thursday that the US Food and Drug Administration issued a complete response letter indicating that glepaglutide to treat short bowel syndrome did not provide sufficient evidence to confirm the efficacy and safety of the proposed dose for market approval.

The drugmaker said it will continue engaging with the FDA to determine the necessary steps for US regulatory approval.

Zealand Pharma plans to begin a phase 3 trial in 2025, aimed at supporting marketing authorizations for glepaglutide in regions outside the US and the European Union, while also providing additional confirmatory evidence for a resubmission in the US, the company said.

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