XERIS PHARMACEUTICALS RECEIVES U.S. FDA APPROVAL FOR GVOKE (GLUCAGON), THE FIRST READY-TO-USE STABLE LIQUID GLUCAGON FOR SEVERE HYPOGLYCEMIA
First approval for Xeris is based on positive efficacy and safety results from multiple clinical studies
GVOKE is the first premixed, prefilled, premeasured liquid glucagon offering ease of use for pediatric and adult patients with diabetes ages 2 years and above or caregivers to rapidly treat severe hypoglycemic events
Company to host conference call today at?12:30 pm ET
CHICAGO--(BUSINESS WIRE)--Sep. 10, 2019--?Xeris Pharmaceuticals, Inc.?(Nasdaq: XERS), a specialty pharmaceutical company leveraging its novel technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations, 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 pediatric and adult patients with diabetes ages 2 years and above. GVOKE is the first glucagon product approved that can be administered via a prefilled syringe (GVOKE PFS) or auto-injector (GVOKE HypoPen?), vastly reducing the steps to prepare and administer glucagon in the event of severe hypoglycemia, or dangerously low blood sugar levels. These innovative formats are designed to provide the reliability of a ready-to-use liquid glucagon while making it easier for patients or caregivers to administer quickly and simply. GVOKE will be available in two doses: a 0.5 mg/0.1 mL dose for pediatric patients and a 1 mg/0.2 mL dose for adolescent and adult patients. GVOKE is contraindicated in patients with pheochromocytoma, insulinoma, and patients with a known hypersensitivity to glucagon or to any of the excipients in GVOKE. ?Everyone managing diabetes is at risk for developing severely low blood sugar, or hypoglycemia, and we know this can quickly progress from a mild event to an emergency situation. The availability of GVOKE - the first ready-to-use liquid glucagon option - brings confidence to patients, parents and caregivers that these challenging events can be easily and rapidly resolved,? said?Davida Kruger, MSN, APN-BC, BC-ADMCertified Nurse Practitioner,?Henry Ford Health System,?Division of Endocrinology, Diabetes and Bone Disorders,?Detroit, Michigan. 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 (NCT02656069, NCT03091673, NCT03439072). The studies demonstrated 100% treatment success in children and 99% treatment success in adults. Usability?research?evaluating the GVOKE PFS and GVOKE HypoPen demonstrated nearly 100% success rates in administering a full dose of glucagon using the simple 2-step administration process. The most common adverse reactions in adults were nausea, vomiting, injection site edema, and headache. In pediatric and adolescent patients, the most common adverse reactions were nausea, hypoglycemia, vomiting, headache, abdominal pain, hyperglycemia, injection site reactions and discomfort, and urticaria. Approximately 80% of side effects seen were mild. "Until now, many people may have been hesitant to use conventional glucagon kits because the complex preparation felt confusing and perhaps overwhelming. With GVOKE as a new glucagon option, we gain an easy to use and effective solution to a dangerous and stressful event," said?Jeff Hitchcock, founder and president of Children with Diabetes. "The approval of GVOKE is an important step forward for people with diabetes. Severe hypoglycemia is a terrifying and dangerous diabetes complication. This new option will make treatment easier and faster in the event of an emergency,? said?Aaron J. Kowalski, Ph.D., President and CEO of JDRF. ?While we celebrate this approval as Xeris? first commercial product, more importantly, this milestone is a positive step forward for the diabetes community as the first premixed, prefilled, and premeasured liquid glucagon to effectively treat severe hypoglycemia in both adults and children with diabetes,? said?Paul R. Edick, Chairman and Chief Executive Officer of?Xeris Pharmaceuticals. ?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 4-6 weeks and the auto-injector in 2020.? Conference Call Details Xeris Pharmaceuticals?will host a conference call and webcast today,?Tuesday, September 10, 2019?at?12:30 pm Eastern Time. The conference call can be accessed by dialing 866-951-8137 for domestic callers and 270-215-9500 for international callers. Please provide the operator with the conference ID 6588821 to join the conference call. The conference call will be available via webcast under the Investors section of Xeris' website at?www.xerispharma.com. An archive of today's webcast will be available on Xeris? website for 60 days following the call. Indication GVOKE? is indicated for the treatment of severe hypoglycemia in patients with diabetes ages 2 years and above. Important Safety Information Contraindications GVOKE is contraindicated in patients with pheochromocytoma, insulinoma, and known hypersensitivity to glucagon or to any of the excipients in GVOKE. Allergic reactions have been reported with glucagon and include anaphylactic shock with breathing difficulties and hypotension. Warnings and Precautions- GVOKE is contraindicated in patients with pheochromocytoma because glucagon may stimulate the release of catecholamines from the tumor. If the patient develops a dramatic increase in blood pressure and a previously undiagnosed pheochromocytoma is suspected, 5 to 10 mg of phentolamine mesylate, administered 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, GVOKE administration may directly or indirectly (through an initial rise in blood glucose) stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia. GVOKE is contraindicated in patients with insulinoma. If a patient develops symptoms of hypoglycemia after a dose of GVOKE, give glucose orally or intravenously.
- Allergic reactions have been reported with glucagon. These include generalized rash, and in some cases, anaphylactic shock with breathing difficulties and hypotension. GVOKE is contraindicated in patients with a prior hypersensitivity reaction.
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Source:?Xeris Pharmaceuticals, Inc. Investor Contact? Allison Wey Senior Vice President, Investor Relations and Corporate Communications awey@xerispharma.com Xeris Media Contact? media@xerispharma.com