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.

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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.

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