FDA announced the approval of the glucagon (Gvoke) injection for the treatment of severe hypoglycemic events in diabetic patients ages 2 and up on September 10.
The US Food and Drug Administration has announced the approval of glucagon (Gvoke) injection for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes age 2 or older to Xeris Pharmaceuticals.
The glucagon injection is the first premised, profiled, remeasure liquid glucagon offering for pediatric and adult patients with diabetes for the treatment of severe hypoglycemic events.
"The approval of GVOKE is an important step forward for people with diabetes. Severe hypoglycemia is a terrifying and dangerous diabetes complication. This new option will make treatment easier and faster in the event of an emergency,” said Aaron J. Kowalski, PhD, president and CEO of JDRF.
In a press release, Xeris Pharmaceuticals noted the ready-to-use liquid glucagon will be available in 2 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. The release also noted the drug is is contraindicated in patients with pheochromocytoma, insulinoma, and patients with a known hypersensitivity to glucagon.
The approval is based on the results of 3, phase 3 clinical trials that examined the efficacy, safety and utility of the glucagon injection in treating severe hypoglycemia compared with conventional glucagon emergency kits in adults and children with type 1 diabetes. Results of these trials (NCT02656069, NCT03091673, NCT03439072) revealed 100% treatment success in children and 99% treatment success in adults.
The most commonly reported adverse reactions in adults were nausea, vomiting, injection site edema, and headache. Among pediatric and adolescent patients, the most common adverse reactions were nausea, hypoglycemia, vomiting, headaches, abdominal pain, hyperglycemia, injection site reactions and discomfort, and urticaria.
Additionally, Xeris Pharmaceuticals noted in their release they expect the pre-filled syringe to be available within 4 to 6 weeks of the Sept. 10 approval and for the auto-injector to be available in 2020.
“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,” said Paul Edick, chairman and CEO of Xeris.