Xeris Pharmaceuticals (NSDQ:XERS) said yesterday that the FDA has approved its Gvoke glucagon injection for the treatment of hypoglycemia.
Gvoke is a ready-to-use, room-temperature, stable liquid glucagon designed to treat severe hypoglycemia in pediatric and adult patients with Type 1 diabetes aged two years old or above.
Chicago-based Xeris’ Gvoke may be administered with a pre-filled syringe or with its HypoPen auto-injector. The company’s aim is to provide the reliability of a ready-to-use liquid glucagon while making it easier for patients or caregivers to administer it efficiently, according to a news release.
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, the company added.
In November 2018, Xeris touted data highlighting the safety and efficacy of the Gvoke. In a Phase III trial, researchers compared the glucagon pen to a commercially available glucagon emergency kit (GEK) to treat severe hypoglycemia in 81 adults with Type 1 diabetes. The study found that the pen resolved symptoms in 11.6 minutes, compared to 13.1 minutes for the GEK.
In a separate usability study, 14 of 16 participants successfully administered a complete injection using Xeris’ glucagon pen, compared to just 5 of 16 for the GEK. In a validation study among 75 adults, 98.7% of participants successfully used the glucagon pen, Xeris said.
The company also noted that three separate Phase III trials of Gvoke demonstrated 100% treatment success in children and 99% treatment success in adults.
“The approval of Gvoke is an important step forward for people with diabetes. Severe hypoglycemia is a terrifying and dangerous diabetes complication. This new option will make treatment easier and faster in the event of an emergency,” JDRF president & CEO Aaron Kowalski said in the news release.
“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 pre-mixed, pre-filled, and pre-measured liquid glucagon to effectively treat severe hypoglycemia in both adults and children with diabetes,” added Xeris CEO Paul Edick. “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 four to six weeks and the auto-injector in 2020.”
Shares of XERS were up +3.2% at $10.55 per share in mid-morning trading today.
