The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for dasiglucagon HypoPal® Rescue Pen (Zealand Pharma) for the treatment of severe hypoglycemia.

Dasiglucagon is a glucagon analog formulated in a ready-to-use aqueous solution for subcutaneous administration. The submission includes data from three phase 3 trials in adult and pediatric patients. In a pivotal phase 3 trial involving 168 adults with type 1 diabetes, dasiglucagon was associated with a median time to blood glucose recovery of 10 minutes vs 40 minutes with placebo, and 12 minutes with GlucaGen (P <.001). 

“We are pleased by the FDA’s acceptance of the NDA for the dasiglucagon HypoPal® rescue pen, several weeks ahead of the anticipated response date,” said Adam Steensberg, Executive Vice President, Research and Development, and Chief Medical Officer at Zealand Pharma. “It marks an important step toward bringing a potential treatment option to people with diabetes at risk of severe hypoglycemia.”

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A Prescription Drug User Fee Act (PDUFA) date of March 27, 2021 has been set for the application.

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