Zealand Set To Take On Lilly After Zegalogue US Approval

The groundwork has been laid and Zealand Pharma A/S can now finalize launch plans for Zegalogue, the Danish group's first approved product, after getting the green light in the US for the severe hypoglycemia treatment.

A few days earlier than a Prescription Drug User Fee Act decision date of 27 March, the US Food and Drug Administration has approved Zegalogue (dasiglucagon) injection for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged six years and above. The approval was based on three Phase III studies of Zegalogue in children aged 6 to 17 and in adults with type 1 diabetes, with the primary endpoint – an increase in blood glucose of ≥20 mg/dL from time of administration without additional intervention within 45 minutes – being achieved across all groups