The Food and Drug Administration (FDA) has approved Zegalogue® (dasiglucagon) for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes 6 years of age and older.
Zegalogue is a glucagon analogue that is formulated in a ready-to-use aqueous solution for subcutaneous administration. The approval was based on data from 3 double-blind, placebo-controlled phase 3 trials in adult and pediatric patients with type 1 diabetes.
In a study involving 170 adults (ClinicalTrials.gov: NCT03378635), dasiglucagon was associated with a median time to plasma glucose recovery of 10 minutes vs 40 minutes with placebo (P <.001), and 12 minutes with glucagon for injection. Similarly, in a trial of 45 adult patients (ClinicalTrials.gov: NCT03688711), the median time to plasma glucose recovery was statistically shorter for dasiglucagon (10 minutes) compared with placebo (35 minutes) (P <.001).
Among pediatric patients 6 to 17 years of age weighing at least 20kg (N=42) (ClinicalTrials.gov: NCT03667053), the median time to plasma glucose recovery was statistically significantly shorter for dasiglucagon (10 minutes) vs placebo (30 minutes) (P <.001), and was numerically similar to glucagon for injection (10 minutes).
“The magnitude and consistency of effect seen in the phase 3 pivotal studies is clinically meaningful as minutes matter in severe hypoglycemia,” said Dr Jeremy Pettus, MD, Assistant Professor of Medicine at the University of California San Diego.
As for safety, the most common adverse reactions reported in studies were nausea, vomiting, headache, diarrhea, and injection site pain. Zegalogue is contraindicated in patients with pheochromocytoma because of the risk of substantial increase in blood pressure, and in those with insulinoma as administration may result in hypoglycemia.
Zegalogue is supplied as a 0.6mg/0.6mL single-dose autoinjector or prefilled syringe for subcutaneous injection. The product should be stored in a refrigerator but can be kept at room temperature for up to 12 months. Each device contains a single-dose of dasiglucagon and cannot be reused. An additional 0.6mg dose from a new device may be administered if there has been no response after 15 minutes.
Zegalogue is expected to be available in the US in June 2021.
1. Zealand Pharma announces FDA approval of Zegalogue® (dasiglucagon) injection, for the treatment of severe hypoglycemia in people with diabetes. [press release]. Copenhagen, Denmark and Boston, MA: Zealand Pharma; March 22, 2021.
2. Zegalogue [prescribing information]. Søborg, Denmark: Zealand Pharma A/S. 2021.