Zealand's Zegalogue (dasiglucagon) Receives the US FDA's Approval for the Treatment of Severe Hypoglycemia
Shots:
- The approval is based on efficacy results from P-III studies involve assessing Zegalogue vs PBO in children aged 6-17yrs. and in adults with T1D
- The study met its 1EPs showed an increase in blood glucose of ≥20 mg/dL within 45 minutes- the median time to blood glucose recovery (10min vs 30-45min)- following injection of 0.6 mg/0.6 ml of therapy- 99% of patients recovered within 15 minutes in adults
- Zegalogue will be available in both an auto-injector and a prefilled syringe to treat hypoglycemia in patients with diabetes aged ≥6yrs.
Ref: GlobeNewswire | Image: Zealand Pharma
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