FDA approved Gvoke

Xeris Pharmaceuticals, Inc. (Nasdaq Stock Code: XERS) is a professional pharmaceutical company. Recently, the US Food and Drug Administration (FDA) approved Xeris Pharmaceutical Company's new drug Gvoke (glucagon) injection, a ready-to-use, room-temperature stable liquid glucagon, for the treatment of severe hypoglycemia in children and adults with diabetes mellitus aged 2 years and over.

Gvoke is the first glucagon product approved by pre-installed syringes (Gvoke PFS) or automatic syringes (Gvoke HypoPen). It greatly reduces the step level of preparation and administration of glucagon in severe or dangerous hypoglycemia. These innovative forms aim to provide the reliability of ready-to-use liquid glucagon, while making it easier for patients or nurses to manage quickly and simply. Gvoke will be divided into two doses: 0.5 mg/0.1 mL for pediatric patients and 1 mg/0.2 mL for adolescents and adults. Gvoke is prohibited for pheochromocytomas, insulinomas and patients known to be allergic to glucagon or any excipient in Gvoke.

FDA approval was based on positive results from three phase 3 clinical trials that assessed the efficacy, safety and practicability of Gvoke in the treatment of severe hypoglycemia compared with conventional glucagon first aid kits for adults and children with type 1 diabetes (NCT02656069, NCT03091673, NCT03439072). These studies show that 100% of children and 99% of adults are successful in treatment. Evaluating the availability of Gvoke PFS and Gvoke HypoPen showed that the success rate of full-dose glucagon was close to 100% using a simple two-step administration method. The most common adverse reactions in adults are nausea, vomiting, edema at the injection site 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. About 80% of the side effects are mild.