Glepaglutide

The FDA issued a Complete Response Letter for Zealand Pharma's glepaglutide NDA, citing insufficient evidence for efficacy and safety. Zealand plans further dialogue with the FDA and a Phase 3 trial in 2025, aiming for U.S. approval and European submission. Glepaglutide targets short bowel syndrome treatment.

Zealand Pharma received a Complete Response Letter from the FDA for glepaglutide, a treatment for short bowel syndrome with intestinal failure. The FDA requested an additional trial for efficacy and safety confirmation. Zealand Pharma plans a Phase 3 trial in 2025 for global marketing authorizations and U.S. resubmission.

Zealand Pharma received a Complete Response Letter from the FDA for glepaglutide's NDA for treating short bowel syndrome, requiring an additional trial. Glepaglutide showed significant effects in reducing parenteral support in a Phase 3 trial. Zealand plans a new Phase 3 trial in 2025 and a European Marketing Authorization Application submission.

The FDA issued a Complete Response Letter for Zealand Pharma's glepaglutide NDA, a long-acting GLP-2 analog for treating short bowel syndrome with intestinal failure. The FDA recommended an additional clinical trial for efficacy and safety confirmation. Zealand remains committed to advancing glepaglutide for SBS patients dependent on parenteral support.

The FDA issued a Complete Response Letter for Zealand Pharma's glepaglutide NDA, citing insufficient evidence for efficacy and safety. Zealand plans further dialogue with the FDA and a Phase 3 trial in 2025, aiming for U.S. approval and European submission. Glepaglutide targets short bowel syndrome treatment.

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.

The FDA is set to decide on ten drug applications, including Ionis' olezarsen for familial chylomicronemia syndrome, Lexicon's sotagliflozin for type 1 diabetes, AstraZeneca and Daiichi Sankyo's Dato-DXd for non-squamous NSCLC, Zealand Pharma's glepaglutide for short bowel syndrome, Rhythm Pharmaceuticals' Imcivree for genetic obesity in children, Checkpoint Therapeutics' cosibelimab for cutaneous squamous cell carcinoma, Mirum's chenodiol for cerebrotendinous xanthomatosis, Bristol Myers Squibb's subcutaneous Opdivo, and Neurocrine's crinecerfont for congenital adrenal hyperplasia.

FDA decisions in December include BeiGene's Tevimbra for gastric cancer, Ionis Pharma's Olezarsen for familial chylomicronemia syndrome, Lexicon Pharma's Zynquista for type 1 diabetes, AstraZeneca's Datopotamab deruxtecan for lung cancer, Zealand Pharma's Glepaglutide for short bowel syndrome, Rhythm Pharma's IMCIVREE for obesity in children, Soleno's DCCR for Prader-Willi syndrome, Checkpoint's Cosibelimab for skin cancer, Mirum's Chenodiol for cerebrotendinous xanthomatosis, Bristol-Myers' subcutaneous Opdivo, and Neurocrine's Crinecerfont for congenital adrenal hyperplasia.