Xeris Pharmaceuticals announced the European Commission (EC) has approved Ogluo? (glucagon) injection for the treatment of severe hypoglycemia in adults, adolescents, and children aged 2 years and over with diabetes mellitus. The marketing authorization is valid in all 27 countries of the European Union, plus Iceland, Norway, and Liechtenstein. As the EC decision was received after the end of the Brexit transition period, Xeris will complete a further administrative step in order to obtain a license in Great Britain. No re-examination of clinical data by the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) is expected.

“This EU approval for Ogluo is a major milestone for Xeris and a significant advancement in the treatment of severe hypoglycemia for the diabetes community in Europe. Hypoglycemia is the #1 side effect of insulin, and severe hypoglycemia is the most urgent emergency any person with diabetes could face. Ogluo, the first pre-mixed auto-injector for severe hypoglycemia, can help offset the inherent risk associated with insulin,” said Paul R. Edick, Chairman and Chief Executive Officer of Xeris Pharmaceuticals. “We are preparing to launch Ogluo later this year, while simultaneously seeking a commercialization partner in which to broaden the availability of Ogluo to more European countries.”

The EC approval was supported by data from a Phase 3, multi-center, randomized controlled, non-inferiority study. The study was conducted among 132 adults with type 1 diabetes in Europe and North America to evaluate the liquid stable glucagon auto-injector as a treatment for severe hypoglycemic events compared with Novo Nordisk’s GlucaGen? HypoKit?. The results demonstrated comparable efficacy between the two groups in achieving a plasma glucose of greater than 3.89 mmol/L (>70 mg/dL) or a relative increase of 1.11 mmol/L (≥20 mg/dL) in plasma glucose concentration within 30 minutes of administration. The study also found that time to resolution of hypoglycemia symptoms as well as time to resolution of the overall feeling of hypoglycemia were comparable. No safety or tolerability concerns were noted. In this study, the most common adverse reactions were nausea and vomiting.

“Hypoglycemia is a neglected complication of glucose-lowering therapy in patients with diabetes mellitus. Attempts made at intensive glycemic control invariably increases the risk of hypoglycemia. In patients experiencing severe hypoglycemia an increase in deaths up to six-fold has been associated to diabetes in comparison to those not experiencing severe hypoglycemia. Patients with diabetes should be evaluated for the risk of clinically important hypoglycemia and have access to ready-to-use glucagon,” said Thomas Pieber, MD, Professor of Medicine, Chair, Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Austria.

Gvoke? PFS and Gvoke HypoPen? (glucagon injection), the first prescription, ready-to-use, pre-mixed, pre-measured glucagon injection, were approved by the FDA in September 2019 for use in the United States. Gvoke is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes ages 2 years and above. Ogluo received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in December 2020 and the European Commission (EC) granted the marketing authorization on 11 February 2021. Ogluo is indicated for the treatment of severe hypoglycemia in adults, adolescents, and children aged 2 years and over with diabetes mellitus.