Zegalogue approved by European CHMP for treating hypoglycaemia

Severe hypoglycaemia in people with diabetes could soon be treated by Zegalogue after the Committee for Medicine Products for Human Use (CHMP) has recommended granting marketing authorisation for the drug.

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.

Results from two trials have revealed that the treatment of insulin-induced hypoglycaemia with Zegalogue reduced the time required to increase plasma glucose compared with placebo.

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 authorisation has been granted by the European Commission.

For more information, click here.

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