MAA submitted to the European Medicines Agency for dasiglucagon for treatment of severe hypoglycemia in diabetes – Novo Nordisk + Zealand Pharma

Zealand Pharma A/S a biotechnology company focused on the discovery and development of innovative peptide-based medicines, announced it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for dasiglucagon injection for the treatment of severe hypoglycemia in adults, adolescents, and children aged 6 years and over with diabetes mellitus. Dasiglucagon injection was approved by the FDA in March 2021 under the brand name Zegalogue.

The approval was based on results from three pivotal trials in adults and children with diabetes, showing a median time to blood glucose recovery from severe hypoglycemia of 10 minutes following injection of 0.6 mg/0.6 mL of dasiglucagon. In these Phase III trials, the most common adverse events reported ( greater than 2%) were nausea, vomiting, headache, diarrhea, and injection site pain in adults; and nausea, vomiting, headache and injection site pain in pediatric patients.

In September 2022, Zealand entered into a global license and development agreement with Novo Nordisk A/S to commercialize Zegalogue.