Xeris Pharmaceuticals, Inc. announced today that it has received regulatory approval from the U.S. Food and Drug Administration (FDA) for Gvoke™ (glucagon) injection.
Gvoke is a ready-to-use, room-temperature stable liquid glucagon for the treatment of severe hypoglycemia (low blood sugar levels) in pediatric and adult patients with diabetes ages 2 years and above.
According to Xeris, Gvoke is the first glucagon product approved that can be administered via a prefilled syringe (Gvoke PFS) or auto-injector (Gvoke HypoPen™), vastly reducing the steps to prepare and administer glucagon in the event of severe hypoglycemia.
“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,” said Davida Kruger, MSN, APN-BC, BC-ADM, a certified nurse practitioner, Henry Ford Health System, Division of Endocrinology, Diabetes and Bone Disorders, in Detroit, MI in a statement.
“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,” she added.
The FDA’s approval is based on positive results from three phase 3 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 showed 100% treatment success in children and 99% treatment success in adults.
Usability research evaluating the Gvoke PFS and Gvoke HypoPen demonstrated nearly 100% success rates in administering a full dose of glucagon using the simple 2-step administration process.
The most common adverse reactions in adults were nausea, vomiting, injection site edema, and headache.
In pediatric and adolescent patients, the most common adverse reactions were nausea, hypoglycemia, vomiting, headache, abdominal pain, hyperglycemia, injection site reactions and discomfort, and urticaria. Approximately 80% of the side effects seen were mild.
“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 chief executive officer of Xeris Pharmaceuticals.
“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,” he added in a press release.
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 with pheochromocytoma, insulinoma, and patients with a known hypersensitivity to glucagon or to any of the excipients in Gvoke.
For complete details, view the company press release.
Xeris Pharmaceuticals. (2019, September 10, 2019). Xeris Pharmaceuticals Receives U.S. FDA Approval for GVOKE™ (glucagon), the First Ready-to-use Stable Liquid Glucagon for Severe Hypoglycemia. Retrieved September 11, 2019, from https://www.businesswire.com/news/home/20190910005829/en