Xeris Pharmaceuticals bags GVOKE FDA approval for severe hypoglycemia

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GVOKE FDA approval : Xeris Pharmaceuticals has bagged approval from the US Food and Drug Administration (FDA) for GVOKE (glucagon) injection for the treatment of severe hypoglycemia associated with diabetes in people, aged two years and above.

GVOKE is a ready-to-use, room-temperature stable liquid glucagon. It is now the first FDA-approved glucagon product that can be administered through a prefilled syringe – GVOKE PFS or auto-injector – GVOKE HypoPen. The approval means that the steps involved in the preparation and administration of glucagon in cases of severe hypoglycemia, or dangerously low blood sugar levels, are significantly reduced, said Xeris Pharmaceuticals.

GVOKE will be available in two doses – a 0.5 mg/0.1 mL dose for pediatric patients, and a 1 mg/0.2 mL dose for adolescent and adult patients. GVOKE should not be used in patients having pheochromocytoma, insulinoma, and also for patients having a known hypersensitivity to glucagon or to any of the excipients in the approved drug.

Commenting on GVOKE FDA approval, Paul R. Edick – Chairman and CEO of Xeris Pharmaceuticals, said: “While we celebrate this approval as Xeris’ first commercial product, more importantly, this milestone is a positive step forward for the diabetes community as the first premixed, prefilled, and premeasured 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 to accommodate the community’s preferences starting with our pre-filled syringe in 4-6 weeks and the auto-injector in 2020.”

GVOKE FDA approval has been driven by positive data from three phase 3 clinical trials, which assessed its efficacy, safety, and utility in the treatment of severe hypoglycemia in comparison to conventional glucagon emergency kits in adults and children with type 1 diabetes.

The NCT02656069, NCT03091673, NCT03439072 phase 3 studies showed 99% treatment success in adults, and 100% treatment success in children, said Xeris Pharmaceuticals.

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