FDA Approves First Ready-to-Use Stable Liquid Glucagon for Severe Hypoglycemia

The U.S. Food and Drug Administration (FDA) recently approved a ready-to-use, room-temperature stable liquid glucagon for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes ages 2 years and above. Xeris Pharmaceuticals is marketing this new glucagon injection as GVOKE.

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, or dangerously low blood sugar levels. These formats are designed to provide the reliability of a ready-to-use liquid glucagon while making it easier for patients or caregivers to administer quickly and simply. 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.

“The advantage of this injection over the other injections is the other injections really required mixing, reconstituting during a period of tremendous anxiety when a loved one is unconscious and unable to recover from hypoglycemia without any intervention,” says Henry Anhalt, DO, vice president of Medical Affairs at Science 37 in Los Angeles. “When you’re in a state of an emergency situation it’s really hard to expect people to be able to mix it, administer it, and do all of that in the face of a very anxiety-provoking episode.”

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 (NCT02656069, NCT03091673, NCT03439072). The studies demonstrated 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.

“Here you have something that’s already mixed in a syringe, so you don’t have to mix it,” Anhalt says. “It’s already mixed. It’s stable in a mixture. And up until now, we were unable to be able to figure out how to keep glucagon stable in a liquid solution. So if you would reconstitute glucagon, you would have to use it in short order.”

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 side effects seen were mild. GVOKE is contraindicated in patients with pheochromocytoma, insulinoma, and patients with a known hypersensitivity to glucagon or to any of the excipients in GVOKE.

“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,” says Aaron J. Kowalski, PhD, president and CEO of JDRF.

“What we’ve seen over the last two months represents a tremendous advance in the care of people living with diabetes,” Anhalt says. “We have the nasal glucagon [Baqsimi], and now we have this stable liquid glucagon, so all of these things I think really represents significant advances, and that the members should be aware that there are options out there that go beyond what they’ve traditionally been using. It’s good time to sort of step back and reevaluate whether there are ways that we can leverage new discoveries towards improving the outcomes in those patients.”

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