The US FDA has approved dasiglucagon (Zegalogue 0.6 mg/0.6 mL, Zealand Pharma) autoinjector and prefilled syringe for the treatment of severe hypoglycemia in people with diabetes aged 6 and older.
The product has a shelf-life of 36 months at refrigerated temperatures and is stable for up to 12 months at room temperature.
Dasiglucagon is currently in phase 3 trials as a SC infusion for treating congenital hyperinsulinemia, and in phase 2 trials as part of a bihormonal artificial pancreas pump system.
The FDA approval was based on results from three randomized, double-blind, placebo-controlled phase 3 studies of dasiglucagon in children age 6 to 17 years and adults with type 1 diabetes.
The primary endpoint was time to achieving an increase in blood glucose of 20 mg/dL or greater from time of administration without additional intervention within 45 minutes. That endpoint was achieved in all three studies, with a median time to blood glucose recovery of 10 minutes overall, with 99% of adults recovering within 15 minutes.
The most common adverse events reported in 2% or more of study participants were nausea, vomiting, headache, and injection site pain in both children and adults. Diarrhea was also reported in adults.
Full launch is expected in late June 2021.
Source: FDA