Glucagon Injection for Severe Hypoglycemia Granted FDA Approval

Officials with the FDA have approved Xeris Pharmaceuticals’ glucagon injection (Gvoke) for the treatment of severe hypoglycemia in patients with diabetes, ages 2 years and older.

This glucagon product is comprised of ready-to-use, room-temperature stable liquid, and is the first of its kind approved by the agency for administration via a prefilled syringe (Gvoke PFS) or auto-injector (Gvoke HypoPen), according to the specialty pharmaceutical company. The glucagon injection is designed to reduce the steps and time needed to prepare and administer medicine for 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, Certified Nurse Practitioner, Henry Ford Health System, Division of Endocrinology, Diabetes and Bone Disorders, Detroit, Michigan, in a prepared statement.

This product is contraindicated in patients with pheochromocytoma, insulinoma, and patients with a known hypersensitivity to glucagon.

Xeris’ glucagon injection will be available in 2 doses: 0.5 mg/0.1 mL dose for pediatric patients and 1 mg/0.2 mL dose for adolescent and adult patients.

The FDA’s approval is based on positive results from a trio of phase 3 clinical trials evaluating the efficacy, safety, and utility of the product in treating severe hypoglycemia when compared with conventional glucagon emergency kits among adults and children with type 1 diabetes. These studies demonstrated 100% treatment success in children and 99% treatment success in adults.

Approximately 80% of adverse effects seen were mild. 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.

Reference

Xeris Pharmaceuticals Receives U.S. FDA Approval for GVOKE™ (glucagon), the First Ready-to-use Stable Liquid Glucagon for Severe Hypoglycemia [news release]. Chicago, IL; September 10, 2019: Xeris Pharmaceuticals website. Xeris Pharmaceuticals Receives U.S. FDA Approval for GVOKE™ (glucagon), the First Ready-to-use Stable Liquid Glucagon for Severe Hypoglycemia. Accessed September 11, 2019.