The first nasally administered glucagon product has been approved by the US Food and Drug Administration (FDA) to treat severe hypoglycemia.
Baqsimi is first nasal glucagon product to receive US approval to treat severe hypoglycemia occurs when blood glucose levels fall very low, and can lead to seizures or coma if not treated quickly.
The glucagon treatments that have been approved, to date, involve a mixing process followed by an injection into muscle.
Baqsimi, developed by Eli Lilly, is the first licensed glucagon product that is not delivered by injection and does not require a multistep mixing process, which can be daunting for people administering glucagon via injection.
This drug has been approved for people with diabetes as young as four years old, and could help parents treat their children more easily due to its simple-to-use process.
The FDA approved Baqsimi for general use in the US after the drug was tested among people with people with type 1 diabetes of varying ages across three studies. The findings suggested the nasal formula worked as well as when glucagon is injected into the body.
Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said: “This new way to administer glucagon may simplify the process, which can be critical during an episode [of hypoglycemia], especially since the patient may have lost consciousness or may be having a seizure. In those situations, we want the process to treat the suffering person to be as simple as possible.”
A Lilly spokesperson said: “Baqsimi is the first and only nasally administered glucagon, and it was designed with severe hypoglycaemia rescue in mind. It is compact, portable and ready to use (no reconstitution required) in a single, fixed, 3 mg dose.”
Lilly submitted Baqsimi to regulatory agencies in Europe last year with a decision expected sometime this year.