Xeris Pharmaceuticals, Inc. (Nasdaq: XERS) announced on 10/23/18 that its new drug application (NDA) for its ready-to-use, room-temperature stable liquid glucagon rescue pen for the treatment of severe hypoglycemia in people with diabetes has been accepted for review by the U.S. Food and Drug Administration (FDA). The FDA has assigned a PDUFA (Prescription Drug User Fee Act) goal date for completion of the review of the glucagon rescue pen NDA of June 10, 2019.
“The FDA acceptance of our NDA for review, is an important milestone for Xeris. If approved, the Xeris glucagon rescue pen would be the first ready-to-use, liquid-stable glucagon in an auto-injector to treat severe hypoglycemia. Compared to the current glucagon rescue option for people with diabetes who are at risk for severe hypoglycemia, the Xeris glucagon rescue pen would eliminate the need for reconstitution and dramatically simplify the preparation and administration process,” said Paul R. Edick, Chairman and Chief Executive Officer of Xeris Pharmaceuticals. “We believe that our glucagon rescue pen has the potential to make an important difference in the lives of people with diabetes.”
The 505(b)2 NDA is based on positive results from multiple Phase 3 clinical trials of the efficacy, safety, and utility of the Xeris glucagon rescue pen auto-injector in treating severe hypoglycemia when compared with currently marketed glucagon emergency kits among adults, children and adolescents with type 1 diabetes (NCT02656069, NCT03091673, NCT03439072). Key study results illustrating the efficacy and tolerability of the glucagon rescue pen for both adults and children with diabetes were presented during the 78th Scientific Sessions of the American Diabetes Association (ADA), June 22-26, 2018.
Glucagon is the standard of care for treating severe hypoglycemia. According to the American Diabetes Association (ADA), glucagon should be prescribed for all individuals at increased risk of clinically significant hypoglycemia, defined as blood glucose <54 mg/dL (3.0 mmol/L).
Hypoglycemic events of any severity are a daily concern for people with diabetes. Mild or moderate hypoglycemia can occur multiple times a month. Severe hypoglycemia is characterized by severe cognitive impairment, requiring external assistance for recovery, and can be extremely frightening for patients and caregivers. Severe hypoglycemia can result in cardiovascular disease, seizure, coma, and, if left untreated, death. These severe hypoglycemic events can occur multiple times a year. Such events require emergency assistance from another person or caregiver such as a family member, friend, or co-worker.