Xeris announced that the Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for its ready-to-use glucagon rescue pen for the treatment of severe hypoglycemia in patients with diabetes. If approved, it would be the first room-temperature stable liquid glucagon in an auto-injector formulation.
“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 CEO of Xeris Pharmaceuticals.
The NDA included findings from multiple Phase 3 trials evaluating the safety, efficacy, and utility of the Xeris glucagon rescue pen auto-injector to treat severe hypoglycemia vs currently available glucagon emergency kits in children, adolescents, and adults with type 1 diabetes. In one study (N=80), the data showed similar speed to relief between the Xeris glucagon auto-injector (GAI) and the conventional glucagon emergency kit (GEK) for autonomic and neuroglycopenic symptoms, as well as global feelings of hypoglycemia.
Another study (N=80) found comparable efficacy between GAI- and GEK-treated patient groups with all patients being successfully rescued from insulin-induced hypoglycemia without other rescue therapy. Almost all patients (97.4%) who received GAI achieved a plasma glucose >70mg/dL or at least a 20mg/dL increase within 30 minutes of glucagon. Also, findings from the Human Factors usability and reliability studies showed the functional efficacy of the Xeris glucagon rescue pen.
The FDA has set a Prescription Drug User Fee Act (PDUFA) date for June 10, 2019.
For more information visit XerisPharma.com.