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# Zealand Pharma NDA Filed for Diabetes Rescue Pen
- URL: https://www.fdaweb.com/zealand-pharma-nda-filed-for-diabetes-rescue-pen/
- Published: 2020-05-14T12:00:00.000Z
- Updated: 2026-09-14T16:14:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146796

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.