The European Medicines Agency (EMA) Committee for Medicinal Products (CHMP) has recommended approval of the first nasal glucagon product (Baqsimi, Eli Lilly Nederland BV) for treatment of severe hypoglycemia in patients with diabetes aged 4 years and older, according to an agency news release.
The FDA approved USA Baqsimi in July.
Baqsimi is a novel formulation of glucagon that comes in a single-use dispenser and can be administered through the nose by caregivers. Patients do not need to inhale or breathe deeply after dosing, enabling drug delivery even in unconscious patients.
The efficacy and safety of Baqsimi was demonstrated in two studies of 83 and 70 adults with diabetes and insulin-induced hypoglycemia.
"Baqsimi adequately increased blood sugar levels within 30 minutes of administration and demonstrated to be as efficient and safe as injected glucagon," the EMA said in the statement. Similar results were observed in a pediatric study of 48 patients over the age of 4 years with type 1 diabetes.
The most commonly reported adverse events were headache, nausea, vomiting, upper respiratory tract irritation, watery eyes, redness of eyes, and itchiness. Side effects of Baqsimi are similar to injectable glucagon, with the addition of nasal and eye-related symptoms because of the way the medicine is administered.
To ensure proper use of Baqsimi, the CHMP recommended a demonstration kit with a training device, an administration leaflet, and an instructional video.
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