Zealand Pharma gets CHMP approval for dasiglucagon for severe diabetes hypoglycemia

On May 31, 2024, Zealand Pharma, a biotechnology company listed on Nasdaq (ZEAL) and known for its innovative peptide-based medicines, revealed that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had issued a favorable opinion. This recommendation is for the approval of dasiglucagon solution for injection as a treatment for severe hypoglycemia in adults, adolescents, and children aged 6 and older with diabetes mellitus.

Adam Steensberg, CEO of Zealand Pharma, expressed satisfaction with the European regulatory authorities' recommendation. He highlighted this development as a significant milestone in their mission to make dasiglucagon widely available to diabetes patients globally through their collaboration with Novo Nordisk, a leading player in the diabetes sector.

The positive CHMP opinion will now be forwarded to the European Commission (EC), which will make the final decision on granting marketing authorization in the European Union (EU). Zealand Pharma anticipates a decision within approximately three months. This follows the earlier approval of dasiglucagon injection by the U.S. FDA in March 2021, where it is marketed under the brand name Zegalogue®.

Zegalogue® received U.S. FDA approval on March 22, 2021, for treating severe hypoglycemia in both pediatric and adult patients aged 6 and above. In the U.S., it is available as both an autoinjector and a prefilled syringe. The approval was supported by data from three pivotal trials in adults and children with diabetes, which demonstrated a median time of 10 minutes to blood glucose recovery after administering a 0.6 mg/0.6 mL dose of dasiglucagon. Common side effects observed in these Phase 3 trials included nausea, vomiting, headache, diarrhea, and injection site pain in adults, with similar adverse events reported in pediatric patients.

In September 2022, Zealand Pharma entered into a global licensing and development agreement with Novo Nordisk A/S to commercialize Zegalogue®. Under this agreement, Zealand stands to receive up to DKK 265 million in various milestones related to development, regulatory approval, manufacturing, and sales. Additionally, Zealand will earn tiered royalties ranging from high single-digit to low double-digit percentages on global net sales of Zegalogue®, which Novo Nordisk will market. Zealand remains responsible for certain regulatory, development, and manufacturing activities, including the Marketing Authorization Application (MAA) submission to the EMA, to facilitate further global development and approval outside the U.S. Zealand retains all intellectual property rights to other dasiglucagon development programs not covered under this license.

Zealand Pharma, founded in 1998 and headquartered in Copenhagen, Denmark, with a presence in the U.S., has a robust pipeline with more than ten drug candidates in clinical development. Two of its products have already reached the market, and three others are in late-stage development. Zealand maintains development partnerships with several pharmaceutical companies and has commercial agreements for its marketed products.

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