Zealand Pharma Announces FDA Approval of Zegalogue (dasiglucagon) injection, for the Treatment of Severe Hypoglycemia in People with Diabetes

Company announcement – No. 16 / 2021

Zealand Pharma Announces FDA Approval of Zegalogue (dasiglucagon) injection, for the Treatment of Severe Hypoglycemia in People with Diabetes

• Zegalogue will be available in both an auto injector and a prefilled syringe for the treatment of severe hypoglycemia in patients with diabetes age 6 or older
• Approval based on results from three pivotal trials in adults and children with diabetes, showing median time to blood glucose recovery from severe hypoglycemia of 10 minutes following injection of 0.6 mg/0.6 mL Zegalogue
• Company to host conference call Tuesday, March 23 at 1:00PM CET (8:00AM ET)

Copenhagen, DK and Boston, MA, U.S. March 22, 2021 – Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078,) a biotechnology company aspiring to deliver innovation with novel peptide therapeutics, announced today that the U.S. Food and Drug Administration (FDA) has approved Zegalogue (dasiglucagon) injection for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 years and above.

“This approval will help enable appropriate children and adults with diabetes to be able to address sudden and severe hypoglycemia, which can quickly progress from a mild event to an emergency,” said Dr. Jeremy Pettus, MD, Assistant Professor of Medicine at the University of California San Diego. “The magnitude and consistency of effect seen in the Phase 3 pivotal studies is clinically meaningful as minutes matter in severe hypoglycemia. Zegalogue provided resolution of severe hypoglycemia following administration, with a median time to blood glucose recovery of 10 minutes across these clinical studies.”

Severe hypoglycemia is an acute, life-threatening condition resulting from a critical drop in blood glucose levels associated primarily with insulin therapy and is one of the most feared complications of diabetes treatment¹. Children with diabetes on insulin are particularly affected, with 7 out 100 children up to the age of 18 reporting severe hypoglycemia in the previous 6 months². While patients have the ability to monitor and adjust their blood glucose levels to remain in proper glycemic control, it’s not always possible to prevent a severe hypoglycemic event.