UK's MHRA approves Xeris' Ogluo

The UK’s Medicines and Healthcare Regulatory Agency (MHRA) has approved Ogluo (glucagon) injection for the treatment of severe hypoglycemia in adults, adolescents, and children aged two years and over with diabetes mellitus, the drug’s developer, Xeris Pharmaceuticals (Nasdaq: XERS), has announced.

The company’s shares were up 3.4% at $4.00 pre-market.

In February, the European Commission (EC) approved Ogluo. As the EC 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 authorization is valid in the UK and all 27 countries of the European Union, Iceland, Norway, and Liechtenstein.