Gvoke Approved to Treat Hypoglycemia

September 10, 2019 – The U.S. FDA has approved GvokeTM (glucagon) injection, manufactured by Xeris Pharmaceuticals. It is the first ready-to-use, shelf-stable liquid glucagon to receive FDA approval, and is indicated to treat severe hypoglycemia in adult and pediatric patients who are at least two years old and have diabetes.

Severe hypoglycemia is a potentially fatal medical emergency that occurs when blood sugar concentrations drop so low the affected individual requires outside assistance for treatment. Signs include confusion, slurred speech, impaired coordination, muscle weakness, fatigue, seizures, and loss of consciousness. In patients who have diabetes, the condition can be triggered by circumstances that include missed or delayed meals after taking diabetes medication, an excess of diabetes medication in the bloodstream, and an increase in exercise.

Gvoke is the first FDA-approved glucagon product that can be administered via prefilled syringe (Gvoke PFS) or auto-injector (Gvoke HypoPenTM). This reduces the number of steps for administration compared to current standard-of-care treatments. These treatments may require several steps for preparation, including unsealing a vial of glucagon powder, injecting sterile water into the vial, mixing the glucagon solution, and then drawing the solution into a syringe for administration.

In clinical studies, Gvoke demonstrated 100% treatment success in children and 99% treatment success in adults. Usability research demonstrated an almost 100% success rate in administering a full dose of glucagon using the two-step administration processes for Gvoke PFS and Gvoke HypoPen.

Recommended dosing for adults and pediatric patients at least 12 years of age is 1mg given by subcutaneous (SC) injection in the event of hypoglycemia. For patients under two to 12 years of age, the recommended dose is based on weight – 0.5mg for patients who weigh less than 45kg (99 pounds) and 1mg for those who weigh 45kg or more. Emergency assistance should be sought immediately after using Gvoke to appropriately address the hypoglycemia event. If the patient does not respond within 15 minutes of treatment, the weight-appropriate dose can be repeated while awaiting emergency assistance. Oral carbohydrates should be given once the patient has responded to treatment.

Gvoke PFS is expected to launch in October 2019, with Gvoke HypoPen following in 2020. Both will have a wholesale acquisition cost (WAC) of $280.80 for one device, or $561.60 for two devices.