The US FDA has granted approval to glucagon nasal powder 3 mg (Baqsimi) for the treatment of severe hypoglycaemia in people with diabetes ages four years and above.
The formulation is the first and only nasally administered glucagon, Eli Lilly and Company said.
It is compact, portable and ready to use in a single, fixed, 3 mg dose.
In adult patients, the nasal formulation showed comparable efficacy to injectable glucagon.
Two randomized, multicentre, open-label, 2-period crossover trials compared a 3 mg dose of nasally administered glucagon nasal powder to a 1 mg dose of glucagon for injection for the treatment of insulin-induced hypoglycaemia.
Study 1 included 70 adult patients with type 1 diabetes. Study 2 included 83 adult patients with type 1 or type 2 diabetes; 80 patients were included in the efficacy analysis of Study 2. Primary efficacy measure was the proportion of patients achieving treatment success.
The drug demonstrated noninferiority to glucagon for injection in both studies in raising blood glucose after insulin-induced hypoglycaemia, with 100% of patients treated with the formulation and 100% of glucagon for injection-treated patients achieving treatment success in Study 1, and 98.8% and 100%, respectively, in Study 2. Treatment success was defined as an increase in plasma glucose levels to = 70 mg/dL or a =20 mg/dL rise in plasma glucose from nadir within 30 minutes of receiving the study glucagon.
In Study 1, the mean nadir blood glucose was 54.5 mg/dL for Baqsimi and 55.8 mg/dL for glucagon for injection. In Study 2, the mean nadir blood glucose was 44.1 mg/dL for Baqsimi and 47.1 mg/dL for glucagon for injection.