Xeris, a rival to Lilly and Novo, gets FDA nod for glucagon kit 

Xeris Pharmaceuticals has opened another front in its fight to win market share from Eli Lilly and Novo Nordisk with the FDA approval of its Gvoke Kit for the treatment of severe hypoglycemia.

Chicago-based Xeris already provides Gvoke in the U.S. as an autoinjector and prefilled syringe. The products compete with Novo Nordisk’s GlucaGen HypoKit, which features an eight-step preparation process, and Lilly’s nasally administered glucagon formulation Baqsimi. All of the products enable the administration of glucagon to treat severe hypoglycaemia.

The FDA approval of Gvoke Kit positions Xeris to cater to patients who prefer to draw up their own doses of glucagon using a vial and syringe rather than use the autoinjectors and prefilled syringes it already sells.

While Gvoke Kit features more steps that need to be taken before administration than Xeris’ other delivery formats, it still offers some potential advantages over other products. Notably, Gvoke Kit has a ready-to-use liquid glucagon that eliminates the need to reconstitute the medicine before delivery, as is required when administering GlucaGen HypoKit. 

Xeris is now working to get Gvoke Kit to patients. The goal is to complete manufacturing scale-up and make the product available in the U.S. early in the first quarter of next year. Xeris secured approval of Gvoke Kit on the strength of a pharmacokinetic study demonstrating bioequivalence to the prefilled syringe formulation. 

The existing products in the Gvoke portfolio generated sales of $8.8 million in the second quarter. Xeris said its share of the retail glucagon market is now up to around 16%, and Gvoke prescriptions topped 21,000 for the first time.