Xeris Pharma get European OK for its Ogluo
Following a positive recommendation two months ago from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), US specialty drug company Xeris Pharmaceuticals (Nasdaq: XERS) on Friday said that 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.
News of the approval pushed Xeris’ shares up 3.2% to $6.84 by close of trading on Friday.
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.
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