The US Food and Drug Administration on Wednesday authorised the Baqsimi nasal powder to treat severe hypoglycemia in patients with diabetes aged four and older.
The agency said that Baqsimi nasal powder is the first glucagon therapy approved for the emergency treatment of severe hypoglycemia that can be administered without an injection. Baqsimi, which is administered into the nose, will come in a single-use dispenser that can be given to someone suffering from a severe hypoglycemic episode. Baqsimi increases blood sugar levels in the body by stimulating the liver to release stored glucose into the bloodstream.
This approval was granted to Eli Lilly and Company (NYSE:LLY).
The efficacy and safety of the company's 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 paediatric study of 48 patients over the age of four with type 1 diabetes, similar results were observed.
Severe hypoglycemia occurs when a patient's blood sugar levels fall to a level where he or she becomes confused or unconscious or suffers from other symptoms that require assistance from another person to treat. Typically, severe hypoglycemia occurs in people with diabetes who are using insulin treatment. It has the opposite effect of insulin, which lowers blood sugar levels, the FDA concluded.
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