The FDA on Tuesday approved the GVOKE glucagon injection system, which features a liquid glucagon formulation that is stable at room temperature, for treatment of severe episodes of hypoglycemia among adults and children older than 2 years with type 2 diabetes, according to a press release from Xeris Pharmaceuticals.
“Everyone managing diabetes is at risk for developing severely low blood sugar, or hypoglycemia, and we know this can quickly progress from a mild event to an emergency situation,” Davida Kruger, MSN, APN-BC, BC-ADM, a certified nurse practitioner in the Henry Ford Health System’s division of endocrinology, diabetes and bone disorders in Detroit, said in the release. “The availability of GVOKE — the first ready-to-use liquid glucagon option — brings confidence to patients, parents and caregivers that these challenging events can be easily and rapidly resolved.”
The GVOKE system works with either a prefilled syringe or auto-injector and can be used to treat those aged at least 2 years with diabetes who experience a severe hypoglycemic event, the release stated. Pediatric patients should be treated with a dose of 0.5 mg/0.1 mL while adolescents and adults should be treated with a dose of 1 mg/0.2 mL, according to the release. The company did note that for those with pheochromocytoma, insulinoma and/or hypersensitivity to glucagon, the GVOKE delivery system is contraindicated.
"The approval of GVOKE is an important step forward for people with diabetes. Severe hypoglycemia is a terrifying and dangerous diabetes complication,” Aaron J. Kowalski, PhD, president and CEO of JDRF, said in the release. “This new option will make treatment easier and faster in the event of an emergency.”
According to Xeris, the system proved largely effective at treating severe hypoglycemia regardless of patient age or delivery with either the syringe or auto-injector in phase 3 clinical trials. These trials also provided evidence that both the syringe and autoinjector can be easily utilized, which is often an issue with older glucagon delivery systems and is an issue being addressed by other developing glucagon delivery products. In addition, adverse events were generally mild and included nausea, hypoglycemia, vomiting, headache, abdominal pain, hyperglycemia, urticaria and adverse reactions at the injection site.
As Endocrine Today previously reported, in a study published in Diabetes Technology & Therapeutics comparing the GVOKE autoinjector with a glucagon emergency kit, the autoinjector led to a higher rate of successful injections (88% vs. 31%; P < .05) and a shorter time of use (47.9 seconds vs. 109 seconds; P < .05).
"Until now, many people may have been hesitant to use conventional glucagon kits because the complex preparation felt confusing and perhaps overwhelming,” Jeff Hitchcock, founder and president of Children with Diabetes, said in the release. “With GVOKE as a new glucagon option, we gain an easy-to-use and effective solution to a dangerous and stressful event.”
Paul R. Edick, chairman and CEO of Xeris Pharmaceuticals, said that the GVOKE syringe should be available in 4 to 6 weeks and that the goal is for a 2020 release for the auto-injector. – by Phil Neuffer