Xeris Pharmaceuticals Announces FDA Approval of GVOKE, the First Ready-to-Use Glucagon Injection for Severe Hypoglycemia in Diabetes Patients

On September 17, 2019, VCBeat (WeChat ID: vcbeat) learned from foreign media reports that biotechnology and pharmaceutical company Xeris Pharmaceuticals (Xeris) announced that its GVOKE injection had received FDA approval for the treatment of severe hypoglycemia in children aged two years and older and adults with diabetes.

Patients with diabetes often experience unstable blood glucose levels and comorbidities, making them prone to symptoms such as hypoglycemia or hyperglycemia. According to World Health Organization statistics, there are over 100 types of diabetic complications, making diabetes the disease with the highest number of known complications.

Patients with severe hypoglycemia will experience symptoms such as profound cognitive impairment, requiring external therapeutic assistance, which places exceptionally high demands on healthcare professionals. Furthermore, this complication can lead to cardiovascular disease, epilepsy, and even coma, necessitating timely and effective treatment for patients.

Xeris, founded in 2005 and headquartered in Chicago, Illinois, USA, is a biotechnology and pharmaceutical company. The company is dedicated to the development and commercialization of ready-to-use injectable therapies for the treatment of conditions such as diabetes and epilepsy. Xeris went public on the NASDAQ Stock Market in the United States in June 2018, trading under the ticker symbol XERS.

GVOKE is the first FDA-approved ready-to-use glucagon injection, combining glucagon with either a pre-filled syringe (GVOKE PFS) or an auto-injector (GVOKE HypoPen) for the effective treatment of severe hypoglycemia. GVOKE is available in two dosages: 0.5 mg/0.1 mL for pediatric patients and 1 mg/0.2 mL for adolescent and adult patients.

GVOKE is contraindicated in patients with pheochromocytoma, insulinoma, or known hypersensitivity to any excipients in GVOKE. Reported allergic reactions to glucagon include anaphylactic shock, dyspnea, and hypotension.

Glucagon is a metabolic hormone secreted by the pancreas that prompts the liver to rapidly convert glycogen, thereby raising blood glucose levels. Together with insulin, glucagon serves as one of the two key hormones in the blood glucose control system, primarily maintaining glucose homeostasis. In patients with diabetes, this regulatory system is impaired, necessitating pharmacological intervention. Xeris’s products not only prevent and manage various forms of hypoglycemia but also treat epilepsy and immunological indications.

“Every patient with diabetes is at risk of experiencing severe hypoglycemia, and GVOKE effectively reduces the likelihood of these events for both patients and healthcare providers,” said Davida Kruger, a healthcare professional.

Paul R. Edick, Chairman and Chief Executive Officer of Xeris, stated, “This represents a positive step forward in diabetes treatment. As the first ready-to-use glucagon injection, GVOKE effectively treats severe hypoglycemia in adult and pediatric patients with diabetes, addressing their medical needs.”

“GVOKE’s approval for market launch marks a significant advancement in the field of diabetes treatment,” said Dr. Aaron J. Kowalski, President and Chief Executive Officer of JDRF, the Juvenile Diabetes Research Foundation. “Severe hypoglycemia is a dangerous complication of diabetes, and GVOKE will serve as an effective therapeutic agent for this condition.”

(Compiled by Xu Xiaoxue)