The U.S. Food and Drug Administration has approved Baqsimi nasal powder, the first glucagon therapy approved for the emergency treatment of severe hypoglycemia that can be administered without an injection.
“This new way to administer glucagon may simplify the process, which can be critical during an episode,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.
“The U.S. list price for a Baqsimi one-pack is $280.80 and $561.60 for a two-pack,” the company said in a statement, adding that Baqsimi is expected to be available in U.S. pharmacies within a month.
The efficacy and safety of Baqsimi nasal powder glucagon to treat severe hypoglycemia was evaluated in two studies of 83 and 70 adults with diabetes, comparing a single dose of Baqsimi to a single dose of glucagon injection in causing a blood sugar response to insulin-induced hypoglycemia.
Baqsimi adequately increased blood sugar levels. In a pediatric study of 48 patients over the age of four with type 1 diabetes, similar results were observed, the FDA said.