FDA approves Gvoke injection, a ready-to-use, room-temperature stable liquid glucagon for the treatment of severe hypoglycemia
Xeris Pharmaceuticals, Inc. announced that it has received regulatory approval from the FDA for Gvoke (glucagon) injection, its ready-to-use, room-temperature stable liquid glucagon for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes ages 2 years and above. Gvoke is the first glucagon product approved that can be administered via a prefilled syringe (Gvoke PFS) or auto-injector (Gvoke HypoPen ), vastly reducing the steps to prepare and administer glucagon in the event of severe hypoglycemia, or dangerously low blood sugar levels
These innovative formats are designed to provide the reliability of a ready-to-use liquid glucagon while making it easier for patients or caregivers to administer quickly and simply. Gvoke 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.
Gvoke is contraindicated in patients with pheochromocytoma, insulinoma, and patients with a known hypersensitivity to glucagon or to any of the excipients in Cvoke.
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