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Xeris Pharmaceuticals Receives European Commission Approval of Ogluo™ (glucagon) Injection for the Treatment of Severe Hypoglycaemia in Adults, Adolescents, and Children Aged 2 Years and Over With Diabetes Mellitus
OGLUO™ Europe’s first and only ready-to-use liquid glucagon for rescue First availability expected in the fourth quarter Approval supported by data from
About this update from Xeris Biopharma Holdings, Inc.
[{"type":"text","content":"\nOGLUO™ Europe’s first and only ready-to-use liquid glucagon for rescue\n\nFirst availability expected in the fourth quarter\n\nApproval supported by data from pivotal Phase 3 study\n\n CHICAGO & DUBLIN--(BUSINESS WIRE)--\nXeris Pharmaceuticals, Inc. (Nasdaq: XERS), a specialty pharmaceutical company leveraging its novel formulation technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations, today 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.\nThis press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210212005054/en/(Photo: Business Wire)\n“This EU approval for Ogluo is a major milestone for Xeris and a significant advancement in the treatment of severe hypoglycaemia for the diabetes community in Europe. Hypoglycaemia is the #1 side effect of insulin, and severe hypoglycaemia is the most urgent emergency any person with diabetes could face. Ogluo, the first pre-mixed auto-injector for severe hypoglycaemia, 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.”\n\nThe EC approval was supported by data from a Phase 3, 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...