FDA OKs First-Ever Nasal Glucagon for Severe Hypos in Diabetes

The US Food and Drug Administration (FDA) has approved the first nasally administered glucagon product (Baqsimi, Eli Lilly and Co) for the treatment of severe hypoglycemia for patients aged 4 years or older who have diabetes.

The nasal powder is the first licensed glucagon product that is not delivered by injection and that does not require a multistep mixing process.

“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,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, in a statement.

Lilly said in a press release: “Baqsimi is the first and only nasally administered glucagon, and it was designed with severe hypoglycemia rescue in mind. It is compact, portable and ready to use (no reconstitution required) in a single, fixed, 3 mg dose.”

The company said it plans to market the new agent at the same price as its current glucagon injection. The US list price for a Baqsimi is $280.80 for a one-pack and $561.60 for a two-pack. The company said it is “in discussions with insurance providers to make Baqsimi available to as many people as possible.

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