Posted by Michael Wonder on 03 Apr 2020
Zealand Pharma submits new drug application to the U.S. FDA for the dasiglucagon HypoPal Rescue Pen for treatment of severe hypoglycemia
31 March 2020 - The dasiglucagon HypoPal Rescue Pen new drug application represents a major milestone in Zealand Pharma’s efforts to bring life changing therapies to people with diabetes.
Zealand Pharma today announced that it has submitted a new drug application to the U.S. FDA for approval of the dasiglucagon HypoPal Rescue Pen for the treatment of hypoglycaemia in people with diabetes.
Zealand’s ready-to-use Dasiglucagon HypoPal Rescue Pen is designed to offer diabetes patients fast and effective treatment for severe hypoglycaemia. In three Phase 3 trials in adults and paediatrics, the primary and all key secondary endpoints were successfully achieved with a median time to blood glucose recovery of only 10 minutes following injection of 0.6mg dasiglucagon.
