Zealand Pharma’s injectable therapy Zegalogue has been approved by the US Food and Drug Administration (FDA) for the treatment of severe hypoglycaemia in people with diabetes.
The FDA approval is supported by efficacy data from three phase III studies of Zegalogue (dasiglucagon) in children aged six to 17 and in adults with type 1 diabetes.
For all three studies, the primary efficacy endpoint was time to plasma glucose recovery, defined as an increase in blood glucose of ≥20 mg/dL from time of administration, without additional intervention within 45 minutes.
This was successfully achieved across both the paediatric and adult populations, with a ‘significantly’ faster median time to blood glucose recovery of ten minutes following Zegalogue administration compared to 30-45 minutes for placebo.
In addition, 99% of patients recovered within 15 minutes in the main phase III adult trial.
“The US FDA approval of Zegalogue is an exciting achievement for both patients and Zealand,” said Emmanuel Dulac, president and chief executive officer of Zealand Pharma.
“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,” he added.