EMA backs Xeris' ready-to-use glucagon for approval, setting up showdown with Novo and Lilly

Xeris Pharmaceuticals has taken a big step toward receiving approval for its ready-to-use formulation of glucagon in the EU. The injectable formulation, branded Ogluo, received a positive opinion from the European Medicines Agency’s (EMA's) drug review committee. 

Securing the support of the EMA’s Committee for Medicinal Products for Human Use means Xeris now just needs the European Commission to review the recommendation and make a final decision. Xeris expects the commission to approve Ogluo for use in severe hypoglycemia in the first quarter of 2021, setting it up to start selling the drug in European countries in the second half of the year. 

Ogluo is designed to make it easier to administer glucagon to treat severe hypoglycemia. In phase 3, Xeris compared the drug to Novo Nordisk’s GlucaGen HypoKit, a product that requires users to work through an eight-step process that involves dissolving a dry powder in sterile water.

The non-inferiority trial randomized 132 adults with Type 1 diabetes to use either Xeris’ liquid stable glucagon autoinjector or Novo’s GlucaGen as a treatment for severe hypoglycemic events. Efficacy, in terms of effect on plasma glucose in the 30 minutes after administration, was comparable in the two cohorts, as was time to resolution and the overall feeling of hypoglycemia.

EMA is treating Ogluo as a hybrid medicine, enabling Xeris to rely partly on data on GlucaGen in its application for approval. The agency permitted the use of GlucaGen data as Ogluo contains the same active ingredient, just made into a ready-to-use formulation for subcutaneous injection. 

In the U.S., Xeris’ glucagon product, Gvoke, is available as a prefilled syringe and an autoinjector, both of which eliminate the need to mix materials prior to administration. Xeris said 99% of people were able to use the autoinjector product, Gvoke HypoPen, correctly when it introduced the formulation in the U.S. over the summer. Some patients may be able to self-administer the product. 

Xeris developed the autoinjector by making a freeze-dried powder that contains glucagon and other materials to prevent aggregation and fibrillation of the active ingredient. The result is a low-volume, highly concentrated solution that is stable at room temperature and suitable for use in autoinjectors.  

In the U.S., Xeris is fighting for market share against the well-established GlucaGen and Eli Lilly’s Baqsimi, another recent entrant to the market. Baqsimi is a nasally administered formulation of glucagon that outsold Xeris’ products over the first nine months of 2020, although the autoinjector version of Gvoke only came to market in July.