FDA approves Zegalogue for severe hypoglycemia in pediatric and adult patients with diabetes.- Zealand Pharma

Zealand Pharma announced that the FDA has approved Zegalogue (dasiglucagon) injection for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 years and above.The FDA approval was based on efficacy results from three randomized, double-blind, placebo-controlled multicenter Phase III studies of Zegalogue in children aged 6 to 17 and in adults with type 1 diabetes. The primary efficacy endpoint for all three studies was time to plasma glucose recovery (treatment success), defined as an increase in blood glucose of at least 20 mg/dL from time of administration, without additional intervention within 45 minutes. The primary endpoint was successfully achieved across the adult and pediatric studies with a significantly faster median time to blood glucose recovery of only 10 minutes following Zegalogue administration compared to 30-45 minutes placebo. In the main Phase III adult trial 99% of patients recovered within 15 minutes. In these studies, the most common adverse events reported (at least 2%) were nausea, vomiting, headache, diarrhea, and injection site pain in adults; and nausea, vomiting, headache, and injection site pain in pediatrics.