The approval is based on results from Phase 3 trials showing high efficacy in adult and pediatric populations.
The US Food and Drug Administration (FDA) has approved dasiglucagon (Zegalogue) for the treatment of severe hypoglycemia in people with diabetes aged 6 years or older.
Granted to Zealand Pharma, the approval was based on positive results from 3 Phase 3 studies, all of which were double-blind, placebo-controlled, multicenter trials. All participants were children aged 6 – 17 years with type 1 diabetes.
The primary endpoint for the studies was time to plasma glucose success—which was defined as an increase in blood glucose of ≥20 mg/dL from time of injection —and without additional intervention within 45 minutes.
This goal was achieved across the pediatric population as well as within the adult population in the corresponding Phase 3 adult trial. Patients who received dasiglucagon achieved a significantly faster median time to blood glucose recovery of only 10 minutes following administration—compared with 30-45 minutes with placebo.
Even more, 99% of adults treated with dasiglucagon recovered within 15 minutes.
The most common adverse events reported in adults were nausea, vomiting, headache, diarrhea, and injection site pain. In children, adverse events were nausea, vomiting, headache, and injection site pain.
“The U.S. FDA approval of Zegalogue is an exciting achievement for both patients and Zealand,” said Emmanuel Dulac, President and CEO, Zealand Pharma, in a statement.
“We would like to thank the trial participants, their families and caregivers, the investigators and their staff, and our employees who made the Zegalogue clinical studies and this resulting approval possible. We are committed to helping people with diabetes manage the potential consequences of their disease and look forward to making Zegalogue available in the U.S. in June.”