A marketing authorization for Zegalogue (dasiglucagon, Zealand Pharma) for the treatment of severe hypoglycemia in patients aged 6 years and older with diabetes has been recommended by the European Medicines Agency (EMA).
Severe hypoglycemia is defined as having low blood glucose levels that requires assistance from another person to treat. Severe hypoglycemia is a complication that can occur in people with diabetes who take insulin and medications including sulfonylureas or prandial glucose regulators.
The condition can lead to serious problems that require emergency treatment. Symptoms of severe hypoglycemia include confusion and disorientation, convulsions, seizures, intense nightmares while sleeping, loss of consciousness, and coma.
The active substance of Zegalogue is dasiglucagon, a glycogenolytic hormone that increases blood glucose concentration by activating hepatic glucagon receptors. This stimulates glycogen breakdown and promotes 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 involving adults and children aged 6 years or older with diabetes.
Results showed that treatment of insulin-induced hypoglycemia with Zegalogue reduced the time required to increase plasma glucose compared with placebo, with a median time to recovery of 10 minutes.
More patients experienced plasma glucose recovery with Zegalogue compared with placebo, the CHMP said.
The most common side effects with Zegalogue are nausea, vomiting, and headache.
Zegalogue will be available as 0.6-mg solution for injection.
Recommendations made by the EMA are subject to ratification by the European Commission.
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