Xeris gets FDA OK for Gvoke
Xeris Pharmaceuticals, a specialty pharmaceutical company has received the Food and Drug Administration’s blessing for Gvoke (glucagon) injection, a 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, according to the company.
The product 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.
“While we celebrate this approval as Xeris’ first commercial product, more importantly, this milestone is a positive step forward for the diabetes community as the first premixed, prefilled, and premeasured liquid glucagon to effectively treat severe hypoglycemia in both adults and children with diabetes. We are actively preparing to introduce Gvoke in two different administration options to accommodate the community’s preferences starting with our pre-filled syringe in 4-6 weeks and the auto-injector in 2020,” said Paul Edick, Xeris chairman and CEO.