CHMP positive recommendation for dasiglucagon for treatment of severe hypoglycemia in diabetes – Zealand Pharma A/S + Novo Nordisk

Zealand Pharma A/S announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending granting marketing authorization for dasiglucagon solution for injection in the treatment of severe hypoglycemia in adults, adolescents, and children aged 6 years and over with diabetes mellitus.

“We are very pleased that the European regulatory authorities have recommended approval of dasiglucagon as a rescue treatment for very low blood sugar in people with diabetes,” said Adam Steensberg, Chief Executive Officer of Zealand Pharma. “This is an important step in achieving our ambition of bringing this product to many more patients around the world through our partnership with Novo Nordisk, a global leader in diabetes.”

The positive opinion from the CHMP will be referred to the European Commission (EC) for a final decision whether to grant marketing authorization in the European Union (EU). Zealand expects this decision within approximately three months. Dasiglucagon injection was approved by the FDA in March 2021 under the brand name Zegalogue.

About Dasiglucagon Injection : Dasiglucagon injection was approved under the brand name Zegalogue by the FDA on March 22, 2021, for the treatment of severe hypoglycemia in pediatric and adult people with diabetes aged 6 years and above. Zegalogue is available in the U.S. in both an autoinjector and a prefilled syringe.

The U.S. approval was based on results from three pivotal trials in adults and children with diabetes, showing a median time to blood glucose recovery from severe hypoglycemia of 10 minutes following injection of 0.6 mg/0.6 mL of dasiglucagon. In these Phase III trials, the most common adverse events reported ( greater than 2%) were nausea, vomiting, headache, diarrhea, and injection site pain in adults; and nausea, vomiting, headache and injection site pain in pediatric patients.

In September 2022, Zealand entered into a global license and development agreement with Novo Nordisk A/S to commercialize Zegalogue. Under the terms of the agreement, Zealand is eligible to receive up to DKK 265 million in development, regulatory, manufacturing and sales-based milestones, as well as tiered royalties ranging from high single-digit to low double-digit percentages on worldwide net sales of Zegalogue to be marketed by Novo Nordisk. Zealand is responsible for certain planned regulatory, development and manufacturing activities, including the Marketing Authorization Application (MAA) to the EMA, to support further development and approval outside of the U.S. Zealand retains all non-licensed intellectual property rights to the company’s other dasiglucagon development program.