FDA accepts filing of HypoPal Rescue Pen for hypoglycemia in people with diabetes.- Zealand Pharma

Zealand Pharma announced that the FDA has accepted for filing the company’s New Drug Application (NDA) for the HypoPal Rescue Pen (dasiglucagon) for the treatment of hypoglycemia in people with diabetes. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of March 27, 2021. Additionally, the FDA has communicated that it is not currently planning on an advisory committee to discuss the application.

Zealand’s ready-to-use dasiglucagon HypoPal rescue pen is designed to offer diabetes patients fast and effective treatment for severe hypoglycemia. In three Phase III trials in adults and pediatrics, 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.1 The Company remains on track for the potential launch of the dasiglucagon HypoPal rescue pen in early 2021.