Zealand Pharma Announces FDA Approval of Zegalogue (dasiglucagon)

Zealand Pharma announced on March 22, that the U.S. Food and Drug Administration (FDA) has approved Zegalogue (dasiglucagon) injection for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 years and above.

“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 Dr. Jeremy Pettus, MD, Assistant Professor of Medicine at the University of California San Diego.

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

Hypoglycemia (Low Blood sugar)

Low blood sugar is when your blood sugar levels have fallen low enough that you need to take action to bring them back to your target range. This is usually when your blood sugar is less than 70 mg/dL. However, talk to your diabetes care team about your own blood sugar targets, and what level is too low for you.

Each person’s reaction to low blood sugar is different. Learn your own signs and symptoms of when your blood sugar is low. Taking time to write these symptoms down may help you learn your own symptoms of when your blood sugar is low. From milder, more common indicators to most severe, signs and symptoms of low blood sugar include:

1. Feeling shaky
2. Being nervous or anxious
3. Sweating, chills and clamminess
4. Irritability or impatience
5. Confusion
6. Fast heartbeat
7. Feeling lightheaded or dizzy
8. Hunger
9. Nausea
10. Color draining from the skin (pallor)
11. Feeling sleepy
12. Feeling weak or having no energy
13. Blurred/impaired vision
14. Tingling or numbness in the lips, tongue or cheeks
15. Headaches
16. Coordination problems, clumsiness
17. Nightmares or crying out during sleep
18. Seizures

Low blood sugar is common for people with type 1 diabetes and can occur in people with type 2 diabetes taking insulin or certain medications. The average person with type 1 diabetes may experience up to two episodes of mild low blood sugar each week, and that’s only counting episodes with symptoms. If you add in lows without symptoms and the ones that happen overnight, the number would likely be higher.

Zegalogue (dasiglucagon)

Severe hypoglycemia is an acute, life-threatening condition resulting from a critical drop in blood glucose levels associated primarily with insulin therapy and is one of the most feared complications of diabetes treatment. Children with diabetes on insulin are particularly affected, with 7 out of 100 children up to the age of 18 reporting severe hypoglycemia in the previous 6 months. While patients have the ability to monitor and adjust their blood glucose levels to remain in proper glycemic control, it’s not always possible to prevent a severe hypoglycemic event.

The FDA approval was based on efficacy results from three randomized, double-blind, placebo-controlled multicenter Phase 3 studies of Zegalogue in children aged 6 to 17 and in adults with type 1 diabetes. The primary efficacy endpoint for all three studies was time to plasma glucose recovery (treatment success), defined as an increase in blood glucose of ≥20 mg/dL from time of administration, without additional intervention within 45 minutes.

The primary endpoint was successfully achieved across the adult and pediatric studies with a significantly faster median time to blood glucose recovery of only 10 minutes following Zegalogue administration compared to 30-45 minutes’ placebo. In the main Phase 3 adult trial 99% of patients recovered within 15 minutes. 

“The U.S. FDA approval of Zegalogue (dasiglucagon) is an exciting achievement for both patients and Zealand,” said Emmanuel Dulac, President and CEO of Zealand Pharma. “We would like to thank the trial participants, their families and caregivers, the investigators and their staff, and our employees who made the Zegalogue clinical studies and this resulting approval possible.

We are committed to helping people with diabetes manage the potential consequences of their disease and look forward to making Zegalogue available in the U.S. in June.  Field sales, market access and medical teams, along with comprehensive patient support services, are in place to maximize awareness to healthcare providers and preparedness to patients affected by severe hypoglycemia.”