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Zealand Pharma announced the US FDA approved dasiglucagon (Zegalogue) for treatment of severe hypoglycemia in patients with diabetes aged 6 and older and the injectable will be available as both an auto injector and a prefilled syringe.
The US Food and Drug Administration has approved dasiglucagon (Zegalogue) for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 years and older, according to a statement from Zealand Pharma.
With approval based on the results of a trio of phase 3 clinical trials, dasiglucagon injection 0.6 mg/0.6 mL will come in the form of both an auto injector and a prefilled syringe and Zealand Pharma expects it to be available for patients in June 2021.
“The US FDA approval of Zegalogue is an exciting achievement for both patients and Zealand,” said Emmanuel Dulac, President and CEO of Zealand Pharma, in the aforementioned 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.”
In the 3 trials used for approval, pediatric patients aged 6-17 years and adult patients were randomized to dasiglucagon or a comparator, which was a glucagon injection 1.0 mg in a pair of trials and a placebo in the remaining trial. The primary efficacy endpoint in all 3 trials 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.
The primary endpoint was achieved across all adult and pediatric studies a significantly faster median time to blood glucose recovery of only 10 minutes following Zegalogue administration compared to 30-45 minutes placebo, according to the statement from Zealand Pharma. Additionally, the statement noted 99% of patients in the adult trial recovered within 15 minutes.
Among adult patients, adverse events occurring in 2% of patients or more included nausea, vomiting, headache, diarrhea, and injection site pain. Among pediatric patients, adverse events occurring in 2% of patients or more included nausea, vomiting, headache, and injection site pain.
The FDA prescribing information notes dasiglucagon is contraindicated in patients with pheochromocytoma due to risk of substantial increase in blood pressure and also among patients with insulinoma due to risk of hypoglycemia.
“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,” said Jeremy Pettus, MD, Assistant Professor of Medicine at the University of California San Diego, in the aforementioned statement. “The magnitude and consistency of effect seen in the Phase 3 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.”