EU approves Ogluo for hypoglycaemia/diabetes.- Xeris Pharmaceuticals

Xeris Pharmaceuticals announced that the European Commission (EC) has approved Ogluo (glucagon) injection for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 2 years and over with diabetes mellitus. The marketing authorisation 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. The EC approval was supported by data from a Phase III, multi-centre, 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 hypoglycaemic 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 (at least 20 mg/dL) in plasma glucose concentration within 30 minutes of administration. The study also found that time to resolution of hypoglycaemia symptoms as well as time to resolution of the overall feeling of hypoglycaemia were comparable. No safety or tolerability concerns were noted. In this study, the most common adverse reactions were nausea and vomiting.