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Brussels, June 3, 2024 – The European Medicines Agency (EMA) has recommended the marketing authorization of Zegalogue (dasiglucagon), developed by Zealand Pharma, for treating severe hypoglycemia in diabetic patients aged six years and older. This decision marks a significant step forward in managing a serious and potentially life-threatening complication of diabetes.
Severe hypoglycemia, characterized by dangerously low blood glucose levels, necessitates intervention from another person to manage. It often affects individuals with diabetes who use insulin or medications such as sulfonylureas or prandial glucose regulators. If left untreated, severe hypoglycemia can lead to confusion, disorientation, convulsions, seizures, intense nightmares, loss of consciousness, and even coma.
Dasiglucagon, the active substance in Zegalogue, is a glycogenolytic hormone that raises blood glucose levels by activating hepatic glucagon receptors. This activation promotes glycogen breakdown and the subsequent release of glucose from the liver, swiftly addressing the hypoglycemic state.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) based its recommendation on robust clinical evidence from two pivotal studies involving both adults and children aged six years and older with diabetes. The results demonstrated that Zegalogue significantly reduced the time required for plasma glucose levels to recover following insulin-induced hypoglycemia, with a median recovery time of just 10 minutes. The studies also indicated that a higher percentage of patients experienced plasma glucose recovery with Zegalogue compared to placebo.
Common side effects reported with Zegalogue include nausea, vomiting, and headache. The medication will be available as a 0.6-mg solution for injection.
The EMA’s recommendation is now subject to ratification by the European Commission. If approved, Zegalogue will provide a new, effective treatment option for managing severe hypoglycemia, potentially improving outcomes and quality of life for many diabetic patients across Europe.
