Glepaglutide

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FDA rejected Zealand Pharma's NDA for glepaglutide, a GLP-2 analog for SBS-IF treatment, due to insufficient evidence on efficacy and safety. A new clinical trial was recommended. Zealand plans further FDA discussions, a European application in 2025, and a Phase 3 trial for non-US/EU markets.

The FDA issued a Complete Response Letter for Zealand Pharma's glepaglutide NDA, citing insufficient evidence for efficacy and safety. Zealand plans further trials and aims for U.S. approval, with a European submission expected in 2025. Glepaglutide targets short bowel syndrome treatment.

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.

Zealand Pharma received a Complete Response Letter from the FDA for glepaglutide's NDA, requiring an additional trial for SBS-IF treatment. Despite disappointment, Zealand Pharma remains confident in glepaglutide's efficacy and safety, planning a Phase 3 trial in 2025 for global approvals and U.S. resubmission.

Zealand Pharma plans a Phase 3 trial in 2025 for glepaglutide, targeting marketing approvals outside the U.S. and EU, and U.S. resubmission. Glepaglutide, a GLP-2 analog, aims to treat short bowel syndrome (SBS) by reducing parenteral support need. The EASE program includes trials assessing glepaglutide's efficacy and safety in SBS patients.

The FDA issued a Complete Response Letter for Zealand Pharma's glepaglutide NDA for short bowel syndrome treatment, citing insufficient evidence for efficacy and safety. Zealand plans further trials and aims for European approval in 2025.