The US Food and Drug Administration (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.
"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 a company statement.
The approval marks the latest step in the development of newer glucagon formulations that are easier to use in hypoglycemic emergencies than the traditional formulation that requires several steps for reconstitution.
The first intranasal glucagon (Baqsimi, Eli Lilly) was approved in the United States in July 2019 for people with diabetes age 4 years and older.
In September 2019, the FDA approved another prefilled glucagon rescue pen (Gvoke HypoPen, Xeris Pharmaceuticals) for the treatment of severe hypoglycemia in adult and pediatric patients age 2 years and older with diabetes.
Dasiglucagon is currently in phase 3 trials as a subcutaneous 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.
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Cite this: FDA Approves New Ready-to-Inject Glucagon Product - Medscape - Mar 23, 2021.