U.S. Food and Drug Administration issues Complete Response - GlobeNewswire
FDA issued a Complete Response Letter for dasiglucagon in congenital hyperinsulinism due to third-party manufacturing issues, not drug safety. Zealand Pharma plans to resubmit NDA in 2024 after resolving deficiencies. Dasiglucagon aims to treat hypoglycemia in CHI patients, addressing a significant unmet medical need.
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U.S. Food and Drug Administration issues Complete Response - GlobeNewswire
FDA issued a Complete Response Letter for dasiglucagon in congenital hyperinsulinism due to third-party manufacturing issues, not drug safety. Zealand Pharma plans to resubmit NDA in 2024 after resolving deficiencies. Dasiglucagon aims to treat hypoglycemia in CHI patients, addressing a significant unmet medical need.