Xeris Pharmaceuticals Inc. said the U.S. Food and Drug Administration approved ready-to-use glucagon rescue pen Gvoke to treat severe hypoglycemia in diabetes patients older than two years.
The Chicago-based pharmaceutical company developed Gvoke as liquid-stable glucagon in an auto-injector that will cut down preparation and administration time in situations where patients have dangerously low levels of blood sugar. Severe hypoglycemia is categorized as a diabetic emergency and can cause cardiovascular disease, cognitive impairment, and when left untreated, can result in death.
The FDA accepted Xeris' application for Gvoke in October 2018 and extended the review period for three months in June. The regulator said the company's response to its information request constitutes a major amendment to the application and the review will take more time.
The approval is based on results from three late-stage trials that showed the effectiveness, utility and safety of the glucagon rescue pen compared to conventional glucagon emergency kits.
Xeris Chairman and CEO Paul Edick said the company is preparing to introduce Gvoke in two different administration options, a pre-filled syringe within four to six weeks and an auto-injector in 2020.
