Posted by Michael Wonder on 30 Apr 2021
Xeris Pharmaceuticals receives U.K. MHRA approval of Ogluo (glucagon) injection for the treatment of severe hypoglycaemia in adults, adolescents and children aged 2 years and over with diabetes mellitus
29 April 2021 - Xeris Pharmaceuticals today announced that the United Kingdom’s Medicines and Healthcare Regulatory Agency (MHRA) has approved Ogluo (glucagon) injection for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 2 years and over with diabetes mellitus.
In February, the European Commission approved Ogluo. As the European Commission decision was received after the end of the Brexit transition period, Xeris was required to complete a further administrative step in order to obtain a license in Great Britain. No re-examination of clinical data by MHRA was required. The marketing authorisation is valid in the United Kingdom, all 27 countries of the European Union, Iceland, Norway, and Liechtenstein.
