FDA OKs Easy-to-Use Glucagon Rescue Pen for Hypos in Diabetes

The US Food and Drug Administration (FDA) has approved a prefilled glucagon rescue pen (Gvoke HypoPen, Xeris Pharmaceuticals) for the treatment of severe hypoglycemia in adult and pediatric patients aged 2 years or older who have diabetes.

The glucagon product can also be administered via a prefilled syringe (Gvoke PFS). Both products contain ready-to-use, room-temperature-stable glucagon and are given via a simple two-step process.

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.

The company plans to launch the prefilled syringe first, in 4 to 6 weeks, followed by the autoinjector (HypoPen) in 2020.

These will compete with another novel, easy-to-use product that was approved in July, nasally administered glucagon (Baqsimi, Lilly), which is given as a single, fixed 3-mg dose for the treatment of severe hypoglycemia in patients with diabetes who are aged 4 years or older.

Everyone with diabetes is at risk of developing low blood sugar, or hypoglycemia, and this can quickly progress from a mild event to an emergency. Severe hypoglycemia is serious and can lead to seizures, coma, potential brain injury, and, if untreated, death.

Glucagon is the standard of care for treating severe hypoglycemia. According to the American Diabetes Association, glucagon should be prescribed for all individuals who are at increased risk for clinically significant hypoglycemia, defined as a blood glucose level <54 mg/dL (3.0 mmol/L).

"My patients have long awaited less intimidating methods for delivering rescue glucagon, and we are rejoicing to have user-friendly, simpler options for this lifesaving medication," Jessica Sparks Lilley, MD, director, Pediatric Diabetes and Lipid Program, Mississippi Center for Advanced Medicine, Madison, told Medscape Medical News.

"The implications for artificial pancreas technology using both insulin and glucagon are promising as well. One barrier to dual-hormone closed-loop systems thus far has been the instability of glucagon," Lilley added.

However, she noted the price of these newer options may be of concern. Although Lilly offers a savings card that can be used to purchase Baqsimi, "the cards don't work for Medicaid patients, and coverage decisions will be left to individual payers for these vulnerable patients," she observed.

No Multistep Mixing Process for Dangerous Event; Easier to Use, Fewer Errors

Baqsimi and the two Gvoke products do not require any multistep mixing process, which has been a drawback to existing glucagon emergency kits. That process requires injecting syringe contents into a vial, mixing, and drawing the solution back into the syringe prior to injecting it into the patient.

This process can be very daunting, and because of the nature of hypoglycemia, it often has to be performed in an emergency situation by the patients themselves or their caregivers, which can lead to errors.

"Until now, many people may have been hesitant to use conventional glucagon kits because the complex preparation felt confusing and perhaps overwhelming," said Jeff Hitchcock, founder and president of Children With Diabetes, in a press release issued by Xeris. "With...a new glucagon option, we gain an easy to use and effective solution to a dangerous and stressful event," he added.

The FDA's approval of the new products is based on positive results from three phase 3 clinical trials that evaluated the efficacy, safety, and utility of Gvoke in treating severe hypoglycemia in comparison with conventional glucagon emergency kits among adults and children with type 1 diabetes, says Xeris. The studies demonstrated 100% treatment success in children and 99% treatment success in adults.

The most common adverse reactions associated with glucagon are nausea, vomiting, and headache.

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.

Lilley has served as a speaker or a member of a speakers' bureau for Insulet and AbbVie. She is also on the advisory board of Medscape.

Follow Lisa Nainggolan on Twitter: @lisanainggolan1 . For more diabetes and endocrinology news, follow us on Twitter and on Facebook .

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