FDA approves Xeris' ready-to-use liquid glucagon Gvoke for severe hypoglycaemia in patients with diabetes

Xeris Pharmaceuticals on Tuesday announced that the FDA has cleared Gvoke (glucagon) for the treatment of severe hypoglycaemia in children and adults aged two years and older with diabetes. According to the company, Gvoke is the first glucagon product approved in the US that can be administered via a prefilled syringe or auto-injector, "vastly reducing the steps to prepare and administer glucagon in the event of severe hypoglycaemia." 

CEO Paul Edick stated "we are actively preparing to introduce Gvoke in two different administration options to accommodate the community's preferences, starting with our pre-filled syringe in four to six weeks, and the [HypoPen] auto-injector in 2020." Xeris indicated that it plans to price both versions of Gvoke at parity to current glucagon products.

The approval was backed by data from Phase III studies evaluating Gvoke versus conventional glucagon emergency kits as a treatment for severe hypoglycaemia in children and adults with type 1 diabetes. Xeris said the studies demonstrated treatment success of 100% in paediatric patients and 99% in adults. It added that usability research showed the pre-filled syringe and HypoPen also had nearly 100% success rates in administering a full dose of glucagon using a simple two-step process. 

In June, the FDA extended its review of Xeris' filing by three months after receiving additional information from the drugmaker. The company also recently reported positive results from a Phase III non-inferiority study comparing the Gvoke auto-injector in type 1 diabetic adults with Novo Nordisk's GlucaGen (glucagon) HypoKit, saying it would use the findings to support EU marketing approval of its product.

Meanwhile, the FDA authorised Eli Lilly's Baqsimi in July as the first nasally administered formulation of rescue glucagon in the US for the treatment of severe hypoglycaemia in patients with diabetes aged four years and older. The therapy has a list price of $280.80 for a one-pack and $561.60 for a two-pack.  

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