FDA OKs Dasiglucagon Injection for Severe Hypoglycemia in Patients With Diabetes

March 23, 2021
Gabrielle Ientile, Assistant Editor

Dasiglucagon (Zegalogue; Zealand Pharma) showed clear clinical benefit in median time to blood glucose recovery, according to 3 clinical trials.

The FDA has approved dasiglucagon (Zegalogue; Zealand Pharma) injection for the treatment of severe hypoglycemia in adults and pediatric patients 6 years and older with diabetes.1

“This approval will help enable appropriate children and adults with diabetes to be able to address sudden and severe hypoglycemia, which can quickly progress from a mild event to an emergency,” said Jeremy Pettus, MD, assistant professor of medicine at the University of California San Diego, in a news release from Zealand Pharma.

Dasiglucagon is administered through an injection, which will be available as an auto injector and a prefilled syringe.

Severe hypoglycemia is one of the most detrimental complications for individuals with diabetes and occurs when there is a significant drop in blood glucose levels, often due to insulin therapy. According to the news release, pediatric patients with diabetes are most affected, as 7 out of 100 children 18 years and younger reported cases of severe hypoglycemia within the last 6 months.

A severe drop in blood sugar level can lead to complications in the brain, in which it doesn’t receive sufficient glucose and stops functioning as it should, according to the American Diabetes Association.2 Patients may experience blurred vision, difficulty concentrating, confused thinking, slurred speech, numbness, and drowsiness in the event of a clinical drop in blood glucose levels.

Approval of dasiglucagon was grounded in 3 randomized, double-blind, placebo-controlled multicenter phase 3 clinical trials, which incorporated both pediatric patients ages 6 to 17 and adult patients with type 1 diabetes.1 Investigators established the primary efficacy end point as time to plasma glucose recovery (treatment success), which they defined as an increase in blood glucose of greater than or equal to 20 mg/dL from time of administration, without additional intervention within 45 minutes.

Dasiglucagon demonstrated a 10-minute median time to blood glucose recovery, which was significantly faster than placebo (30 to 45 minutes). In addition, results of the main phase 3 adult trial reported that 99% of patients recovered within 15 minutes.

For adult patients, the most frequent (≥2%) adverse events (AEs) were nausea, vomiting, headache, diarrhea, and injection site pain. For pediatric patients, AEs included nausea, vomiting, headache, and injection site pain.

“The magnitude and consistency of effect seen in the Phase 3 pivotal studies is clinically meaningful as minutes matter in severe hypoglycemia,” Pettus said. “Zegalogue provided resolution of severe hypoglycemia following administration, with a median time to blood glucose recovery of 10 minutes across these clinical studies.”

References

  1. Zealand Pharma Announces FDA Approval of Zegalogue (dasiglucagon) injection, for the Treatment of Severe Hypoglycemia in People with Diabetes. News Release. GlobeNewswire; March 22, 2021. Accessed March 23, 2021. http://www.globenewswire.com/news-release/2021/03/22/2197267/0/en/Zealand-Pharma-Announces-FDA-Approval-of-Zegalogue-dasiglucagon-injection-for-the-Treatment-of-Severe-Hypoglycemia-in-People-with-Diabetes.html.
  2. Hypoglycemia (Low Blood Sugar). American Diabetes Association. 2021. Accessed March 23, 2021. https://www.diabetes.org/healthy-living/medication-treatments/blood-glucose-testing-and-control/hypoglycemia.