FDA Approves New Ready-to-Use Glucagon Auto-Injector for Diabetic Emergencies

Until just a few years ago, not much was available to help diabetic people in emergency situations. The only emergency glucagon rescue product on the market for people with severe low blood sugar issues was a mix-and-inject kit with a giant needle and a too-long preparation time. But luckily, science is making advancements every day to improve the health and safety of people with this condition.

On March 22, 2021, the U.S. Food and Drug Administration (FDA) gave the green light to a new emergency glucagon pen that can be administered at a moment’s notice. The drug, called Zegalogue, can be purchased as a prefilled syringe, which functions just like an insulin injection, or an auto-injector, which is similar to an EpiPen.

Zegalogue, an analogue for human glucagon, works by kickstarting the pancreas to release glucagon, which tells the liver and muscle cells to convert stored energy into glucose and pump it into the bloodstream to raise blood sugar levels.

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The medication begins working in minutes and usually raises blood sugar by 20 mg/dL or more within 10 minutes. In a phase 3 study in adults, 99 percent of participants recovered from their hypoglycemic episodes within 15 minutes. It can take 35-45 minutes for people to recover without the use of glucagon.

The product hails from Denmark-Based Zealand Pharma but will now be available for sale in the United States. Zealand Pharma is only the third company since 2019 to get a new easy-to-use glucagon approved. In 2019, the FDA approved both Eli Lilly’s nasal glucagon Baqsimi and the Gvoke HypoPen auto-injector and prefilled syringe from Texas-based Xeris Pharmaceuticals.

This is another step away from complicated mix-and-inject kits that have dominated the market for decades, and the availability of another easy-to-use glucagon tool could be instrumental in lowering prices for these emergency products and helping to save so many lives.

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“There is still a large unmet need in the diabetes community,” says Frank Sanders, CEO of Zealand Pharma U.S. in Boston. “We think Zegalogue is an attractive new option.”

Both the prefilled syringe and the auto-injector are one-time-use products that contain 0.6 mg (or 0.6 mL) of liquid glucagon. They will both eventually be sold as singles or two-packs and will come in a protective red plastic case. They are approved for adults and children six years of age and older.

Zegalogue will last for 12 months at room temperature or 36 months if refrigerated. Like other glucagon products, it may cause side effects such as nausea, vomiting, diarrhea, and headaches, mostly due to the quick spike in blood sugar. Some users may also experience pain at the injection site. Adolescents are more likely to experience more side effects than adults and younger children.

Photo: Adobe Stock/RFBSIP

The newest Zegalogue product is scheduled to launch in June 2021 so that it will be available before the next school season. The company has not released pricing information but says it will offer “parity pricing” similar to competing products. That could translate to roughly $280 for a single injector pen or $561 for a two-pack.

Zealand Pharma also says it plans to work with insurers to get coverage and formulary inclusion. It will also offer copay assistance programs and discount cards to help people afford the emergency medication.

Zealand Pharma has some more exciting products in the works, and we can’t wait to see what the future of diabetes emergency care looks like when they come out on the market. For now, we hope this newly approved product will help people with diabetes across the nation feel safer and more secure in the backup tools they have on-hand for emergencies.

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