FDA Approves Dasiglucagon for Severe Hypoglycemia for Diabetes Patients
By Adam Hochron
April 7, 2021
The FDA has approved dasiglucagon injection to treat severe hypoglycemia in patients with diabetes. A release from the manufacturer noted that the treatment will be available as an auto-injector or prefilled syringe for patients age 6 or older.
The dasiglucagon injection was examined in three phase 3 trials involving adults and children with type 1 diabetes. The release noted that the primary efficacy endpoint for all three trials was time to plasma glucose recovery, defined as an increase in blood glucose of ≥20 mg/dL from time of administration without additional intervention within 45 minutes. Across all three trials, the primary endpoint was achieved. The median time to plasma glucose recovery was 10 minutes among those treated with dasiglucagon compared with 30-45-minute median for patients treated with placebo. The release noted that 99% of patients in the main trial recovered within 15 minutes.
“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, from the University of California San Diego, in the release. “The magnitude and consistency of effect seen in the phase 3 pivotal studies is clinically meaningful as minutes matter in severe hypoglycemia.”
The manufacturer’s release noted that the most common adverse events reported during the studies included nausea, vomiting, and headache. Other adverse events included diarrhea and injection site pain. The adverse events were reported in both adults and children enrolled in the trials.