With Supportive Data, Zealand Looks to NDA for Rare Pediatric Hypoglycemia

Zealand Pharma, a biotech company that creates peptide-based medicines, shared positive top-line results for the second Phase III clinical trial of its congenital hyperinsulinism (CHI) drug, dasiglucagon, in pediatric patients.

The positive data is consistent with Zealand’s first Phase III trial. Though that study ultimately failed to meet the main endpoint, there were optimistic signs under certain conditions. If approved, it would become the first new treatment developed specifically for CHI in over thirty years.

CHI is a rare genetic disease that affects infants and toddlers. Those with CHI have a defect in the gene that produces insulin cells, causing the cells to produce too much insulin and putting the child into a state of hypoglycemia.

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