Xeris Pharmaceuticals has received the UK’s Medicines and Healthcare Regulatory Agency (MHRA) approval for Ogluo (glucagon) injection to treat severe hypoglycaemia.
MHRA indicated Ogluo for the treatment of severe hypoglycaemia in adults, adolescents, and children aged two years and above with diabetes mellitus.
The US-based speciality pharmaceutical company leverages novel formulation technology platforms to develop and market ready-to-use injectable and infusible drug formulations.
Available under the brand names Gvoke PFS and Gvoke HypoPen, Ogluo is the first prescription, ready-to-use, pre-mixed, pre-measured glucagon injection, said the company.
Gvoke PFS and Gvoke HypoPen were granted approval by the US Food and Drug Administration (FDA) in September 2019.
In February this year, Ogluo was approved by the European Commission (EC), based on data from a Phase 3 study in 132 adults with type 1 diabetes.
The study evaluated treatment using liquid stable glucagon auto-injector for severe hypoglycaemic events, compared with Novo Nordisk’s GlucaGen HypoKit.
The EC approval follows a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in December 2020.
The marketing authorisation is valid in the UK, all 27 countries of the European Union (EU), Iceland, Norway, and Liechtenstein, said the company.
Xeris is required to complete further administrative steps to obtain a license in Great Britain, as the EC granted approval at the end of the Brexit transition period.
Ogluo is not advised for patients with pheochromocytoma, insulinoma, and known hypersensitivity to glucagon or any of its excipients, along with allergic reactions to glucagon.
Furthermore, the company is actively looking for a marketing partner in the UK, EU, and other regions, and planning to launch the product in select EU countries in Q4 21.
