Zealand Pharma NDA Filed for Diabetes Rescue Pen

Zealand Pharma has filed an NDA for HypoPal (dasiglucagon) rescue pen for treating diabetes patients with severe hypoglycemia. The submission is based on data from pivotal and confirmatory Phase 3 trials, where primary and all key secondary endpoints were successfully achieved with a median time to blood glucose recovery of 10 minutes, the company says. In the pivotal trial, 99% of subjects recovered from the insulin-induced hypoglycemia within 15 minutes following dosing with dasiglucagon, versus 2% with placebo and 95% with GlucaGen. Overall, the company says no safety concerns were documented for dasiglucagon during the trial. Nausea and vomiting were reported with similar numbers for dasiglucagon and GlucaGen (nausea: 55% and 53%, vomiting: 23% and 19%, respectively). Results from a pediatric Phase 3 study announced in 9/2019 also demonstrate that the median time to blood glucose recovery was 10 minutes for dasiglucagon in children, it says.