10 September 2019 - First approval for Xeris is based on positive efficacy and safety results from multiple clinical studies.
Xeris Pharmaceuticals announced today that it has received regulatory approval from the U.S. Food and Drug Administration (FDA) for Gvoke (glucagon) injection, its ready-to-use, room-temperature stable liquid glucagon for the treatment of severe hypoglycemia in paediatric and adult patients with diabetes ages 2 years and above.
The FDA’s approval is based on positive results from three Phase 3 clinical trials evaluating the efficacy, safety, and utility of GVOKE in treating severe hypoglycemia when compared with conventional glucagon emergency kits among adults and children with type 1 diabetes.