Northerner
Admin (Retired)
- Relationship to Diabetes
- Type 1
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 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.
FDA Approves New Ready-to-Inject Glucagon Product
Dasiglucagon is the third of newer-generation glucagon products that don't require multistep reconstitution in emergency hypoglycemic situations.
www.medscape.com