FDA Approves New Glucagon Option from Zealand Pharma
On March 22, 2021, Zealand Pharma announced the FDA approval of Zegalogue in an autoinjector and prefilled syringe. The approval will add two more easy-to-use glucagon options, joining Eli Lilly’s nasal glucagon Baqsimi and Xeris Pharmaceuticals’ GVOKE HypoPen and prefilled syringe.
Slated to be commercially available in the US in June 2021 for ages 6 and older, Zegalogue’s approval follows three clinical trials in adults and children with insulin-dependent diabetes. Following use of Zegalogue in response to severe hypoglycemia, patients showed recovery (an increase in blood glucose of ≥ 1.1 mmol/L20 mg/dL) within 10-15 minutes.
Dasiglucagon is a peptide analog (i.e. a human-created drug designed to mimic the actual hormone) version of glucagon, a naturally occurring hormone that triggers the body to release glucose reserves from the liver to raise blood sugar. In the body of a person with diabetes, this process has to be manually managed. However, partly because easy-to-use glucagon options are fairly new to the market, many people with insulin-dependent diabetes don’t typically carry or know when to use glucagon.
FDA guidance for Zegalogue and other forms of glucagon indicate usage in response to any severe hypoglycemic event, defined as a severe low blood sugar during which the person experiencing the low becomes unable to easily help themselves. A person with diabetes does not need to be experiencing seizures or unconsciousness before dosing glucagon, and it is safer to dose glucagon before either occurs.
For all forms of glucagon, possible side effects after dosing are nausea, vomiting, and headache, with a small number of people also experiencing diarrhea or injection site pain.
This content mentions Lilly, Xeris Pharmaceuticals and Zealand Pharma, active partners of Beyond Type 1.
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