American Regent Launches Gvoke VialDx in Partnership with Xeris Pharmaceuticals

American Regent has commercially launched Gvoke VialDx, a gastrointestinal motility inhibitor for diagnostic aid during radiologic examinations. The product is a result of a partnership between American Regent and Xeris Pharmaceuticals, with Xeris supplying the product and American Regent responsible for commercialization. Gvoke VialDx is indicated for intravenous use in adult patients to temporarily inhibit gastrointestinal tract movement.

American Regent, Inc.®, a subsidiary of Daiichi Sankyo Group, has announced the commercial launch of Gvoke VialDx™ (glucagon injection), a gastrointestinal motility inhibitor indicated for intravenous use as a diagnostic aid during radiologic examinations. This product is the result of a strategic partnership between American Regent and Xeris Pharmaceuticals, Inc. [1].

Gvoke VialDx is designed to temporarily inhibit the movement of the gastrointestinal tract in adult patients, making it an essential tool for radiologic procedures. The product is available in 1-count and 10-count packages, each containing 1 mg per 0.2 mL single-dose vials. It is now available for immediate shipment through wholesalers, distributors, or by contacting American Regent's Customer Support Group at 1-800-645-1706 [1].

The launch of Gvoke VialDx is a significant milestone for both companies. American Regent, known for its expertise in commercializing high-quality sterile injectable products, will handle the commercialization of the product in the U.S. Xeris Pharmaceuticals, Inc., responsible for the product supply, is proud to mark the commercial launch of Gvoke VialDx, which is the first liquid glucagon available for use as a diagnostic aid [1].

Joann Gioia, Vice President and Chief Commercial Officer at American Regent, stated, "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. The addition of Gvoke VialDx to our portfolio aligns perfectly with our mission to provide patients with the essential medicines they need." Kevin McCulloch, President and COO of Xeris, added, "We're proud to mark the commercial launch of Gvoke VialDx in partnership with American Regent. Gvoke VialDx is the first liquid glucagon available for use as a diagnostic aid and provides an important new option for hospitals and clinics. American Regent is a natural partner to commercialize Gvoke VialDx given their longstanding reputation as a leading provider of high-quality sterile injectable products" [1].

Gvoke VialDx is indicated for use in adult patients and is not approved for continuous infusion. It is contraindicated in patients with pheochromocytoma, insulinoma, and glucagonoma, due to the risk of substantial increase in blood pressure, hypoglycemia, and other serious adverse reactions. The product also carries warnings and precautions related to these conditions and others, including the risk of serious hypersensitivity reactions [1].

The most common adverse reactions reported in clinical trials were nausea, dysgeusia, headache, hot flush, and dizziness. Postmarketing experience has also reported cases of necrolytic migratory erythema (NME) and hypoglycemia [1].

American Regent's commitment to US-based manufacturing and quality control ensures that Gvoke VialDx will be available to healthcare providers promptly and reliably. With this launch, American Regent continues to expand its portfolio of essential medicines, aligning with its mission to serve patients' needs effectively [1].

References:
[1] https://www.prnewswire.com/news-releases/american-regent-launches-gvoke-vialdx-glucagon-injection-302539306.html