FDA approves first ready-to-use stable glucagon injection for severe hypoglycemia
Food and Drug Administration has granted approval for first ready-to-use stable liquid glucagon for severe hypoglycemia.
The US Food and Drug Administration has approved glucagon (Gvoke) injection for the treatment of severe hypoglycemia or sudden fall of blood sugar in pediatric and adult patients with diabetes age 2 or older to Xeris Pharmaceuticals. The first approval 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 hypoglycemia or dangerously low blood sugar levels. The pre-filled syringe is expected to be available within 4 to 6 weeks of the Sept. 10 approval and for the auto-injector to be available in 2020.
Xeris Pharmaceuticals, Inc. (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 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-ADM Certified Nurse Practitioner, Henry Ford Health System, Division of Endocrinology, Diabetes and Bone Disorders, Detroit, Michigan.
The approval of Food and Drug Administrationis 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.”
GVOKE™ is indicated for the treatment of severe hypoglycemia in patients with diabetes ages 2 years and above.
Important Safety Information
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.
GVOKE is effective in treating hypoglycemia only if sufficient hepatic glycogen is present. Patients in states of starvation, with adrenal insufficiency or chronic hypoglycemia, may not have adequate levels of hepatic glycogen for GVOKE administration to be effective. Patients with these conditions should be treated with glucose.
Most common (≥10%) adverse reactions associated with GVOKE are nausea, vomiting, and hypoglycemia.
Patients taking beta-blockers may have a transient increase in pulse and blood pressure when given GVOKE. In patients taking indomethacin, GVOKE may lose its ability to raise blood glucose or may even produce hypoglycemia. GVOKE may increase the anticoagulant effect of warfarin.