It has a peculiar name, but its function is important — even life-saving. It’s called Gvoke, and it’s a prefilled glucagon rescue pen that has just been approved by the U.S. Food and Drug Administration (FDA) for the treatment of severe hypoglycemia (low blood sugar) in adults and children with diabetes. The full name is Gvoke HypoPen and it’s made by Xeris Pharmaceuticals, a Chicago-based company that specializes in ready-to-use injectables for a variety of medical purposes.
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Everyone with diabetes runs the risk of developing low blood sugar, which can be a serious condition. If not properly treated, it can lead to brain damage and even death. The accepted way of handling it is by administering glucagon, which is a pancreas-produced hormone that increases blood sugar. The problem has been that the kits for administering glucagon require the user to make a solution by injecting the components into a vial, mixing them, drawing them back into the syringe and then injecting them into the body. It can be awkward — especially in an emergency. Gvoke, the company says, requires no premixing and is instantly useable. The user removes the red cap and pushes the pen down on the skin for five seconds until the window turns red. The pen then autoretracts and locks so it can’t be reused.
The FDA approval of Gvoke came after three clinical trials comparing it with standard glucagon kits used in adults and children with type 1 diabetes. Its effectiveness was determined to be 100% in children and 99% in adults. Two doses will be available — one for pediatric patients and one for teens and adults.
When the FDA approval was announced in early September, Paul R. Edick, Xeris CEO, said, “This milestone is a positive step forward for the diabetes community as the first pre-mixed, pre-filled and pre-measured liquid glucagon to effectively treat severe hypoglycemia in both adults and children with diabetes. We are actively preparing to introduce Gvoke in two different administration options… starting with our pre-filled syringe in 4–6 weeks and the auto-injector in 2020.”
A freelance writer and editor based in the Chicago area, Gustaitis has a degree in journalism from Columbia University.