FDA grants regulatory approval for hypoglycemia treatment
GVOKE injection has received regulatory approval from the FDA for the treatment of severe hypoglycemia in patients with diabetes.
Xeris Pharmaceuticals Inc has announced that it has received regulatory approval from the US Food and Drug Administration (FDA) for GVOKE™ (glucagon) injection. The treatment is a ready-to-use, room-temperature stable liquid glucagon for the treatment of severe hypoglycemia in patients with diabetes ages two years and above.
The studies demonstrated 100 percent treatment success in children and 99 percent treatment success in adults”
GVOKE is the first glucagon product approved that can be administered via a prefilled syringe (GVOKE PFS) or auto-injector (GVOKE HypoPen™), which reduces the steps needed to prepare and administer glucagon in the event of severe hypoglycemia or dangerously low blood sugar levels.
The treatment 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.
“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-ADMCertified Nurse Practitioner, Henry Ford Health System, Division of Endocrinology, Diabetes and Bone Disorders, Detroit, Michigan. “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,”
This 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 percent treatment success in children and 99 percent treatment success in adults.
Usability research evaluating the GVOKE PFS and GVOKE HypoPen demonstrated nearly 100 percent success rates in administering a full dose of glucagon using the two-step administration process. Approximately 80 percent of side-effects seen were mild.