Xeris Pharmaceuticals Gets FDA Nod for Liquid Glucagon

On Sep. 10, 2019, Xeris Pharmaceuticals, a specialty pharmaceutical company specializing in parenteral drug formulations, announced that it has received regulatory approval from FDA for GVOKE (glucagon) injection, its ready-to-use, room-temperature stable liquid glucagon for treating severe hypoglycemia in pediatric and adult diabetic patients.

According to the company, GVOKE is the first glucagon product approved that can be administered via a prefilled syringe or auto-injector, which offers the benefit of reducing the steps to prepare and administer glucagon in the event of severe hypoglycemia, or dangerously low blood sugar levels. The drug 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. The drug is contraindicated in patients with pheochromocytoma, insulinoma, and patients with a known hypersensitivity to glucagon or to any of the excipients in GVOKE.

“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. 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,” said Davida Kruger, board certified-advanced diabetes management-certified nurse practitioner, Henry Ford Health System, Division of Endocrinology, Diabetes, and Bone Disorders, Detroit, MI, in a company press release.

FDA’s approval is based on positive results from three Phase III clinical trials evaluating the efficacy, safety, and utility of GVOKE in treating severe hypoglycemia when compared with conventional glucagon emergency kits among adults and children with type 1 diabetes. The studies demonstrated 100% treatment success in children and 99% treatment success in adults.

"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," said Jeff Hitchcock, founder and president of Children with Diabetes, in the press release.

"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, a non-profit organization that funds type 1 diabetes research, in the press release.

“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 R. Edick, chairman and CEO of Xeris Pharmaceuticals, in the press release. “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 [four to six] weeks and the auto-injector in 2020.”

Source: Xeris Pharmaceuticals