European CHMP recommends approval for use of Zegalogue for treating hypoglycaemia

The Committee for Medicine Products for Human Use (CHMP) has recommended granting marketing authorisation for Zegalogue for the treatment of severe hypoglycaemia in people with diabetes.

Once authorised, the drug will be available as a 0.6 mg solution for injection. Dasiglucagon is the active substance of Zegalogue, which is a glycogenolytic hormone that increases blood glucose concentration by activating hepatic glucagon receptors, stimulating glycogen breakdown and promoting the release of glucose from the liver.

In two studies in children from six years of age and adults with diabetes, treatment of insulin-induced hypoglycaemia with Zegalogue reduced the time required to increase plasma glucose compared with placebo, with a median time to recovery of 10 minutes.

More people experienced plasma glucose recovery with Zegalogue compared with placebo. The most common side effects with Zegalogue are nausea, vomiting and headache.

The full indication is:

• Zegalogue is indicated for the treatment of severe hypoglycaemia in adults, adolescents, and children aged six years and over with diabetes

• Detailed recommendations for the use of this product will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after the marketing authorisationhas been granted by the European Commission.

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