The Food and Drug Administration has approved the supplemental New Drug Application for Gvoke® Kit for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes 2 years of age and older.
Gvoke is a ready-to-use, room-temperature stable liquid glucagon that is administered into the lower abdomen, outer thigh, or outer upper arm. The product is currently available as 1mg and 0.5mg injections as single-dose prefilled syringes (Gvoke PFS) or autoinjectors (Gvoke HypoPen). The approval for Gvoke Kit was supported by a pharmacokinetic study comparing the bioequivalence of 1mg Gvoke Kit administered via a vial and a syringe kit with that of 1mg Gvoke PFS.
The new Gvoke Kit formulation is expected to be available early in the first quarter of 2022 as a 1mg/0.2mL single-dose vial and syringe kit. The kit will contain 1 single-dose sterile syringe with markings for 0.1mL (0.5mg pediatric dose) and 0.2mL (1mg adult dose), and 1 single-dose vial containing 0.2mL of solution.
“Offering three different administration options – Gvoke HypoPen®, Gvoke® PFS, and Gvoke® Kit, allows for greater patient choice in a ready-to-use rescue product for the approximately 6.8 million people in the [United States] who rely on insulin and are at-risk of a severe hypoglycemic event […],” said Paul R. Edick, Chairman and CEO of Xeris. “In particular for patients or caregivers who prefer to draw up their Gvoke rescue dose using a vial and syringe, Gvoke Kit reduces the number of steps by eliminating reconstitution – the most common mistake in correctly administering the conventional glucagon kit.”
Xeris Pharmaceuticals announces approval of supplemental New Drug Application (sNDA) of Gvoke® Kit for the treatment of severe hypoglycemia. News release. Xeris Pharmaceuticals, Inc. Accessed August 23, 2021. https://www.businesswire.com/news/home/20210823005077/en/Xeris-Pharmaceuticals-Announces-Approval-of-Supplemental-New-Drug-Application-sNDA-of-Gvoke%C2%AE-Kit-for-the-Treatment-of-Severe-Hypoglycemia.