This site is intended for healthcare professionals
Latest drug news
  • Home
  • /
  • News
  • /
  • 2021
  • /
  • 3
  • /
  • FDA approves Zegalogue for severe hypoglycemia in ...

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

Read time: 1 mins
Published:24th Mar 2021
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.
Condition: Diabetes + Hypoglycemia
Type: drug

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.