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Zealand Pharma A/S is a biotechnology company dedicated to advancing innovation with new peptide therapies.
It is worth mentioning that Zegalogue is the first and only glucagon analogue used to treat severe hypoglycemia in children 6 years and older and adults with diabetes.
Zegalogue will be available in auto-injectors and pre-filled syringes for the treatment of severe hypoglycemia in diabetic patients 6 years and older.
Severe hypoglycemia is an acute, life-threatening disease, mainly caused by a severe drop in blood sugar levels caused by insulin therapy, and is one of the most worrying complications in diabetes treatment.
Dr.
The FDA's approval is based on the results from 3 randomized, double-blind, placebo-controlled, multi-center Phase 3 clinical studies.
The primary endpoint was successfully achieved in adult and pediatric studies.
In these studies, the most common adverse events (≥2%) reported were nausea, vomiting, headache, diarrhea, and injection site pain in adult patients, and nausea, vomiting, headache, and injection site pain in pediatric patients.
Original source: Zealand Pharma Announces FDA approval of Zegalogue (dasiglucagon) injection, for the Treatment of Severe Hypoglycemia in People with Diabetes
