Zealand’s Zegalogue treatment for hypoglycemia approved by FDA
pharmafile | March 23, 2021 | News story | Manufacturing and Production | FDA, Zealand Pharma, Zegalogue
The FDA have approved Zealand Pharma’s Zegalogue therapy for the treatment of severe hypoglycemia in patients with diabetes.
The approval comes following three randomised, double-blind Phase III trials in children aged six years old and above, and adults with Type 1 diabetes.
The primary endpoint of faster time to plasma glucose recovery was successfully reached, with a median time of 10 minutes achieved by those administered with Zegalogue, as opposed to 30-45 minutes for those on the placebo. In the main Phase III adult trial, 99% of patients recovered within 15 minutes.
Zegalogue will now be available in the US from June as both an auto-injector and a pre-filled syringe for the treatment of severe hypoglycemia in patients with diabetes aged six or older.
Severe hypoglycemia is an acute, life-threatening condition resulting from a critical drop in blood glucose levels. Children with diabetes on insulin are particularly affected, with 7 out of 100 patients up to the age of 18 reporting severe hypoglycemia in the previous six months.
Dr Jeremy Pettus, Assistant Professor of Medicine at the University of California in San Diego, said: “This approval will help enable appropriate children and adults with diabetes to be able to address sudden and severe hypoglycemia, which can quickly progress from a mild event to an emergency.
“The magnitude and consistency of effect seen in the Phase III pivotal studies is clinically meaningful as minutes matter in severe hypoglycemia. Zegalogue provided resolution of severe hypoglycemia following administration, with a median time to blood glucose recovery of 10 minutes across these clinical studies.”
Emmanuel Dulac, President and CEO of Zealand Pharma, added: “The US FDA approval of Zegalogue is an exciting achievement for both patients and Zealand. 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.”
Jack Goddard
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