Xeris Pharmaceuticals receives U.S. FDA approval for Gvoke (glucagon), the first ready-to-use stable liquid glucagon for severe hypoglycaemia

Xeris Pharmaceuticals

10 September 2019 - First approval for Xeris is based on positive efficacy and safety results from multiple clinical studies.

Xeris Pharmaceuticals announced today that it has received regulatory approval from the U.S. Food and Drug Administration (FDA) for Gvoke (glucagon) injection, its ready-to-use, room-temperature stable liquid glucagon for the treatment of severe hypoglycemia in paediatric and adult patients with diabetes ages 2 years and above.

The FDA’s approval is based on positive results from three Phase 3 clinical trials evaluating the efficacy, safety, and utility of GVOKE in treating severe hypoglycemia when compared with conventional glucagon emergency kits among adults and children with type 1 diabetes.

Read Xeris Pharmaceuticals press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , US