The Food and Drug Administration (FDA) has approved Gvoke (glucagon; Xeris Pharmaceuticals) for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 2 years and older.
Gvoke is a ready-to-use, room-temperature stable liquid glucagon that can be administered via a prefilled syringe (Gvoke PFS) or autoinjector (Gvoke HypoPen) into the lower abdomen, outer thigh, or outer upper arm. The approval was based on results from two phase 3 clinical trials (NCT02656069, NCT03439072) in adult patients with type 1 diabetes that evaluated the efficacy and safety of Gvoke 1mg injection compared with conventional glucagon. Patients were brought into a state of insulin-induced hypoglycemia via insulin infusion with a target plasma glucose of <50mg/dL.
Results demonstrated Gvoke to be noninferior to conventional glucagon therapy; 98.7% of patients treated with Gvoke achieved treatment ‘success’, defined as a plasma glucose increase of >70mg/dL or relative increase of ≥20mg/dL, at 30 minutes post-administration compared with 100% in the conventional glucagon group (primary end point).
Additionally, data from an open-label phase 3 trial in 31 pediatric patients aged 2 to 17 years with type 1 diabetes supported the approval of Gvoke. Patients were administered insulin to induce a plasma glucose of <80mg/dL, followed by either Gvoke 1mg or 0.5mg injection. Findings from the study showed all evaluable patients (n=30) achieved a target glucose increase of ≥25mg/dL (primary end point).
Regarding safety, 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.
Gvoke 1mg and 0.5mg injections will be supplied as single-dose prefilled syringes and autoinjectors in 1- or 2-count cartons. The prefilled syringe and HypoPen autoinjector will be available in 4 to 6 weeks and in 2020, respectively.
For more information visit xerispharma.com.