Zegalogue® Is Now Commercially Available in the United States
Today, June 24, 2021, Zealand Pharma announced that Zegalogue® (dasiglucagon) is commercially available in the U.S. in an auto-injector and prefilled syringe, after receiving FDA approval on March 22, 2021. For people with diabetes who self-dose insulin or utilize glucose-regulating medications, there’s a risk for low blood sugar caused when there’s too much insulin in the body, a state also known as severe hypoglycemia. For this reason, anyone who uses medications that impact blood sugar should always have a form of glucagon on hand to respond to potential severe low blood sugar levels.
Based on the efficacy results from Zealand Pharma’ phase 3 study, Zegalogue has been approved for use among children and adults aged 6 or over. In the trial, adults and children experiencing low blood sugar were given a subcutaneous injection of Zegalogue to restore blood glucose to safe levels. The trial found that after Zegalogue administration, patients observed a faster median time of blood glucose recovery—just 10 minutes—when compared to the 30 to 45 minutes in the placebo group. 99 percent of patients recovered within 15 minutes.
“Zegalogue is a unique molecule dasiglucagon, which is an analog of native or human glucagon,” David Kendall, MD, senior global medical advisor at Zealand Pharma tells Beyond Type 2. Kendall says that Zegalogue was created with a number of important characteristics that change how the treatment is prepared, cared for and stored.
Unlike older forms of glucagon where users had to mix a powder and liquid solution immediately before use, Zegalogue remains stable as a liquid. While its unique molecule dasiglucagon is chemically different from glucagon, it is an analog (a human-made drug designed to mimic a naturally occurring hormone or chemical) and has the same effect as human glucagon, according to Kendall. “At the end of the day, it is a glucagon receptor agonist, meaning it triggers or stimulates that receptor to do the things that help raise blood glucose,” Kendall says.
People living with diabetes, as well as family members, caregivers, colleagues and classmates, should be aware of the ease of use of newer glucagon options, available in quick pen injectors and as a nasal spray. A person who is experiencing severe low blood sugar does not need to be unconscious before glucagon is used.
According to Kendall, severe low blood sugar rescue therapies like glucagon have been under prescribed and underutilized. Research shows that glucagon prescriptions are often not filled by people living with diabetes, including five percent of those with prior hypoglycemia incidents that resulted in the usage of emergency care.
In the United States, there are over 34.2 million Americans who live with diabetes. For people with diabetes, achieving glycemic control can be a daily challenge. Roughly 7.4 million Americans with diabetes use one or more formulations of insulin to manage their blood glucose levels.
For commercially insured patients, Zegalogue will be available for purchase at or under $25 for up to two Zegalogue devices per fill. There will also be an opportunity to receive home prescription delivery. For those without insurance or who do not qualify for the copay card, assistance may be available through Zealand Pharma’s Patient Assistance Program. “The commercial availability of Zegalogue brings us one step closer to helping people feel confident and prepared to address the unpredictable nature of severe hypoglycemia,” Frank Sanders, president of U.S. operations for Zealand Pharma, says in a press release.