FDA approves rescue pen for treating severe hypoglycemia
The FDA approved dasiglucagon as an auto injector or prefilled syringe for the treatment of severe hypoglycemia in people with diabetes aged 6 years and older, according to an industry press release.
The approval of Zegalogue injection 0.6 mg (Zealand Pharma) is based on results from three trials with children and adults with diabetes, which showed a median time to blood glucose recovery from severe hypoglycemia of 10 minutes. Dasiglucagon, a human glucagon analogue, has a unique stability profile in a ready-to-use, aqueous solution, according to the company.
“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,” Jeremy H. Pettus, MD, an assistant clinical professor in the UC San Diego School of Medicine, said 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. Zegalogue provided resolution of severe hypoglycemia following administration, with a median time to blood glucose recovery of 10 minutes across these clinical studies.”
Emmanuel Dulac, president and CEO of Zealand Pharma, said the company looks forward to Zegalogue becoming 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 health care providers and preparedness to patients affected by severe hypoglycemia,” Dulac said in the release.
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 years and in adults with type 1 diabetes. The primary efficacy endpoint for all three studies was time to plasma glucose recovery, defined as an increase in blood glucose of at least 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 after Zegalogue administration compared with 30 to 45 minutes with placebo.
For the main phase 3 adult trial, 99% of patients recovered within 15 minutes, according to the release.
The most common adverse events reported during studies were nausea, vomiting, headache, diarrhea and injection site pain.