Marketing approval for Zegalogue (DasigurukagonNew Zealand Pharma has approved the drug for the treatment of severe hypoglycemia in diabetic patients aged 6 and over. Recommended by the European Medicines Agency (EMA).
Severe hypoglycemia is when blood sugar levels are so low that you need help treating it. Severe hypoglycemia is a complication that can occur when people with diabetes take the following medications: Insulin Medications such as sulfonylureas and postprandial glucose regulators.
This condition can cause serious problems that require emergency medical treatment. Symptoms of severe hypoglycemia include confusion or disorientation, convulsions, seizures, intense nightmares during sleep, loss of consciousness, or coma.
The active ingredient in Zegalogue is dasiglucagon, a glycogenolytic hormone that increases blood glucose levels by activating glucagon receptors in the liver, stimulating the breakdown of glycogen and promoting the release of glucose from the liver.
Clinical Evidence
The EMA’s Committee for Medicinal Products for Human Use (CHMP) based its decision on evidence from two studies in adults and children aged six years or older with diabetes.
Results showed that treating insulin-induced hypoglycemia with Zegalogue reduced the time required for plasma glucose to rise compared to placebo, with a mean time to recovery of 10 minutes.
More patients receiving Zegalogue experienced recovery of plasma glucose compared with placebo, according to the CHMP.
The most common side effects of Zegalogue are nausea, vomiting, headache.
Zegalog will be sold as a 0.6 mg injection.
Recommendations by the EMA are subject to ratification by the European Commission.
