The US Food and Drug Administration (FDA) has approved Xeris Pharmaceuticals’ GVOKE (glucagon) injection for the treatment of severe hypoglycaemia in paediatric and adult patients having diabetes, aged two years and above.
GVOKE is a ready-to-use, room-temperature stable liquid glucagon product, which can be administered to the patient using a prefilled syringe or auto-injector.
The liquid glucagon product will be available in a 0.5mg/0.1mL dose for paediatric patients and a 1mg/0.2mL dose for adolescent and adult patients. The firm said that GVOKE should not be given to patients having pheochromocytoma, insulinoma, and patients with a history of hypersensitivity to glucagon or to any of the excipients in the approved liquid glucagon product.
Children with Diabetes founder and president Jeff Hitchcock said: “Until now, many people may have been hesitant to use conventional glucagon kits because the complex preparation felt confusing and perhaps overwhelming. With GVOKE as a new glucagon option, we gain an easy to use and effective solution to a dangerous and stressful event.”
Xeris secured the FDA approval based on the positive findings from three phase 3 clinical trials that assessed the efficacy, safety, and utility of the company’s liquid glucagon product for the treatment of severe hypoglycaemia. This was in comparison with conventional glucagon emergency kits in the NCT02656069, NCT03091673, NCT03439072 trials, which enrolled adults and children with type 1 diabetes.
The three trials delivered 100% treatment success in children and 99% treatment success in adult patients for the liquid glucagon product, said Xeris. The pharma company said that usability research assessing the GVOKE PFS prefilled syringe and GVOKE HypoPen auto-injector yielded almost 100% success rates in giving a full dose of glucagon using the two-step administration process.
Xeris chairman and CEO Paul Edick 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.”