Saturday, June 22, 2024

Diabetes Drug for Severe Hypoglycemia Approved in Europe

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Diabetes patients aged 6 years and older may soon benefit from Zegalogue (dasiglucagon, Zealand Pharma) as the European Medicines Agency (EMA) has recommended marketing authorization for its treatment of severe hypoglycemia. Severe hypoglycemia, characterized by dangerously low blood glucose levels, requires assistance from another person to treat and is a serious complication for those with diabetes who use insulin or certain medications like sulfonylureas or prandial glucose regulators.

Zegalogue’s active substance, dasiglucagon, is a glycogenolytic hormone that raises blood glucose levels by activating hepatic glucagon receptors. This activation stimulates the breakdown of glycogen and promotes the release of glucose from the liver, helping to quickly counteract severe hypoglycemia.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) based its decision on evidence from two clinical studies involving adults and children aged 6 years or older with diabetes. The studies demonstrated that Zegalogue significantly reduced the time required to raise plasma glucose levels compared to placebo, with a median recovery time of just 10 minutes. More patients treated with Zegalogue experienced a rapid recovery in plasma glucose levels compared to those given a placebo. The most common side effects reported were nausea, vomiting, and headache. Zegalogue will be available as a 0.6-mg solution for injection.

A Life-Saving Treatment for Severe Hypoglycemia in Diabetes Patients

Recommendations made by the EMA must be ratified by the European Commission before they become effective. If ratified, this approval will provide a crucial treatment option for severe hypoglycemia in diabetes patients, enhancing their safety and well-being. Severe hypoglycemia is a life-threatening condition for diabetes patients, especially those on insulin or medications like sulfonylureas. It requires immediate treatment, often necessitating external assistance. Symptoms can range from confusion and convulsions to unconsciousness and coma, highlighting the need for rapid and effective intervention.

Zegalogue (dasiglucagon) addresses this urgent need by rapidly increasing blood glucose levels. Dasiglucagon is a hormone that activates hepatic glucagon receptors, stimulating the liver to release glucose and thereby counteracting hypoglycemia. This mechanism is crucial for restoring normal blood glucose levels swiftly and safely.

The EMA’s recommendation for Zegalogue’s approval is based on robust clinical evidence. Two pivotal studies involving adults and children with diabetes showed that Zegalogue significantly reduced the time to plasma glucose recovery. Patients treated with Zegalogue recovered in a median time of 10 minutes, a critical improvement over placebo. The studies also indicated that more patients achieved plasma glucose recovery with Zegalogue than with a placebo, underscoring its efficacy.


A New Milestone in Diabetes Care for Managing Severe Hypoglycemia

Zegalogue’s safety profile is manageable, with the most common side effects being nausea, vomiting, and headache. These side effects are relatively mild compared to the severe risks posed by untreated hypoglycemia. The medication will be provided as a 0.6-mg injection solution, facilitating easy administration in emergencies.

The EMA’s recommendation is a crucial step toward the approval of Zegalogue by the European Commission. If ratified, this drug will offer a vital treatment for severe hypoglycemia, addressing a significant unmet need in diabetes care. It will allow patients to manage their condition more effectively, reducing the risks associated with severe hypoglycemic events.

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The approval of Zegalogue for severe hypoglycemia represents a significant advancement in diabetes care. By providing a rapid and effective treatment option, Zegalogue can help mitigate the serious risks associated with severe hypoglycemia, improving patient safety and quality of life. As the EMA’s recommendation moves toward ratification by the European Commission, Zegalogue stands to become an essential tool in the management of diabetes-related emergencies.


Resource: European Medicines Agency, May 31, 2024

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