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First concentrated, ready-to-dilute liquid glucagon available for growing procedural gastroenterology market

American Regent to commercialize GVOKE VialDx™

Availability is expected in the third quarter of 2025

CHICAGO, March 17, 2025--(BUSINESS WIRE)--Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies, today announced that its supplemental new drug application (sNDA) of Gvoke VialDx™ has received U.S Food and Drug Administration (FDA) approval for use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients.

Xeris also announced it has partnered with American Regent to commercialize Gvoke VialDx. Under the terms of the agreement, Xeris will be responsible for product supply, and American Regent will be responsible for the commercialization of Gvoke VialDx in the U.S. Financial terms were not disclosed.

"We’re excited about the approval of Gvoke VialDx and our partnership with American Regent. Gvoke VialDx has the potential to modernize the handling and administration of glucagon for diagnostic procedures," said Kevin McCulloch, President and COO of Xeris. "American Regent is the perfect partner for Gvoke VialDx given their long history as a leading provider of high quality, sterile injectable products to the hospital and acute care marketplace."

Joann Gioia, Vice President and Chief Commercial Officer at American Regent, said, "We are eager to bring our commercial expertise in the hospital and acute care setting to our partnership with Xeris and contribute to the success of Gvoke VialDx. With an estimated 20 million gastrointestinal endoscopic procedures performed annually, the addition of Gvoke VialDx to our portfolio aligns perfectly with our mission to provide patients with the essential medicines they need."

Gvoke VialDx will be available as a 1-count or 10-count package of 1 mg per 0.2 mL single-dose vials.

Indications and Important Safety Information
Gvoke is an antihypoglycemic agent indicated for subcutaneous use for the treatment of severe hypoglycemia in adult and pediatric patients aged 2 years and older with diabetes.

Gvoke VialDx is a gastrointestinal motility inhibitor indicated for intravenous use as a diagnostic aid for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients.

• Gvoke and Gvoke VialDx are contraindicated in patients with:

  • Pheochromocytoma because of the risk of substantial increase in blood pressure

  • Insulinoma because of the risk of hypoglycemia

  • Prior hypersensitivity reaction to glucagon or to any of the excipients. Serious hypersensitivity reactions have been reported with glucagon, including generalized rash, and anaphylactic shock with breathing difficulties and hypotension

  • Gvoke VialDx is also contraindicated in patients with glucagonoma because of risk of hypoglycemia

• Glucagon may stimulate the release of catecholamines from the tumor. If patient develops a substantial increase in blood pressure and a previously undiagnosed pheochromocytoma is suspected, 5 to 10 mg of phentolamine mesylate intravenously has been shown to be effective in lowering blood pressure

• In patients with insulinoma, administration of glucagon may produce an initial increase in blood glucose; however, glucagon may stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia. If a patient develops symptoms of hypoglycemia after a dose of Gvoke or Gvoke VialDx, give glucose orally or intravenously

• Patients with insufficient hepatic stores of glycogen may not respond to Gvoke for treatment of hypoglycemia. Insufficient hepatic stores of glycogen may be present in conditions such as states of starvation, or in patients with adrenal insufficiency or chronic hypoglycemia

• A skin rash called necrolytic migratory erythema (NME), has been reported post-marketing following continuous glucagon infusion and resolved with discontinuation of the glucagon. Gvoke and Gvoke VialDx are not approved for continuous infusion. Should NME occur, consider whether the benefits of continuous glucagon infusion outweigh the risks

• Gvoke VialDx in patients with diabetes mellitus may cause hyperglycemia. Monitor diabetic patients for changes in blood glucose levels during treatment with Gvoke VialDx and treat hyperglycemia, if indicated

• Gvoke VialDx may increase myocardial oxygen demand, blood pressure, and pulse rate which may be life threatening in patients with cardiac disease. Cardiac monitoring is recommended in patients with cardiac disease during use of Gvoke VialDx, and an increase in blood pressure and pulse rate may require therapy

• Gvoke VialDx administered to patients with glucagonoma may cause secondary hypoglycemia. Test patients suspected of having glucagonoma for blood levels of glucagon prior to treatment and monitor for changes in blood glucose during treatment

• Most common adverse reactions reported for Gvoke in adult patients were nausea, vomiting, injection site edema raised 1 mm or greater, and headache

• Most common adverse reactions reported for Gvoke in pediatric patients were nausea, hypoglycemia, vomiting, headache, abdominal pain, hyperglycemia, injection site discomfort and reaction, and urticaria.

• Most common adverse reactions reported for Gvoke VialDx were nausea, dysgeusia, headache, dizziness and hot flush

• Gvoke and Gvoke VialDx may increase the anticoagulant effect of warfarin; and in patients taking beta-blockers, may have a transient increase in pulse and blood pressure. In patients taking indomethacin Gvoke may lose its ability to raise glucose or may produce hypoglycemia. Concomitant use of anticholinergic drugs with Gvoke VialDx is not recommended. Monitor blood glucose when Gvoke VialDx is used in patients receiving insulin.