Zealand Pharma submits New Drug Application to the U.S. Food and Drug Administration for the Dasiglucagon HypoPal® Rescue Pen for treatment of severe hypoglycemia
- 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
- The submission encompasses three Phase 3 trials which met all primary and key secondary endpoints with a median time to recovery from hypoglycemia of only 10 minutes
- Zealand Pharma remains on-track to build commercial infrastructure in the U.S. for the anticipated Dasiglucagon HypoPal® Rescue Pen launch in 2021
Copenhagen, March 31, 2020 – Zealand Pharma A/S (“Zealand”) (NASDAQ: ZEAL), a Copenhagen-based biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of the Dasiglucagon HypoPal® Rescue Pen for the treatment of hypoglycemia in people with diabetes.
“This is the first of four potential New Drug Applications over the next three years, and is a major milestone for Zealand Pharma,” commented Emmanuel Dulac, President and Chief Executive Officer at Zealand Pharma. “We have a strong commitment toward bringing life changing therapies to patients and believe that the Dasiglucagon HypoPal Rescue Pen addresses a significant and underserved need among people living with diabetes.”
“I am particularly proud that the team was able to deliver on our commitment to filing the New Drug Application for dasiglucagon before the end of the first quarter 2020, despite having to work remotely and under the difficult conditions caused by the COVID-19 crisis,” commented Adam Steensberg, Executive Vice President, Research and Development, and Chief Medical Officer at Zealand Pharma.
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 3 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 FDA typically has a 60-day filing review period to determine whether the NDA is sufficiently complete and acceptable for filing.
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