Xeris Pharmaceuticals (NASDAQ: XERS) shares are rallying premarket on Friday after the company announced that the European Commission has approved the Ogluo injection to treat severe hypoglycemia in adults, adolescents, and children age 2 years and over with diabetes mellitus.
The approval is valid in 27 countries of the European Union plus Iceland, Norway, and Lichtenstein, but as the decision was received after the Brexit transition period, Xeris will need a further administrative step to obtain a licence in the UK.
“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,” said Paul R Edick, chairman and CEO of Xeris.
The approval was supported by data from a Phase 2 multicenter, randomised controlled trial that included 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 plasma glucose of greater than 3.89 mmol/L or an increase of 1.11mmol/L in plasma glucose concentration within 30 minutes of administration. There were no safety or tolerability concerns with the most common adverse reactions being nausea and vomiting.
Xeris said it is preparing to launch Ogluo later this year while searching for a commercialisation partner.
Its shares are up 29.71% premarket at $8.60.