FDA Approves Baqsimi for Severe Hypoglycemia

July 25, 2019
Patrick Campbell

With approval, Baqsimi, which was approved for adults and children as young as 4, becomes the first approved treatment of hypoglycemia that can be administered without an injection.

The US Food and Drug Administration (FDA) has announced the approval of Eli Lilly and Company’s nasal powder glucagon (Baqsimi) for the treatment of severe hypoglycemia.

The nasal powder, which is administered via an intranasal spray, is the first approved treatment for severe hypoglycemia that can be administered without an injection. The spray will come in a single-use dispenser that can be given to a person suffering a severe hypoglycemic episode. 



“This new way to administer glucagon may simplify the process, which can be critical during an episode, especially since the patient may have lost consciousness or may be having a seizure,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research In those situations, we want the process to treat the suffering person to be as simple as possible.”

The safety and efficacy of Baqsimi nasal powder glucagon was evaluated in 2 studies, which involved 83 and 70 adults with diabetes, that compared single dose Baqsimi to a single dose of glucagon injection. Investigators found that Baqsimi adequately increased blood sugar levels. Additionally, similar results were observed in a pediatric study of 48 patients over the age of 4 with type 1 diabetes.

In a press release, the FDA advised Baqsimi should not be taken by patients with pheochromocytoma or who have insulinoma. The release also noted Baqsimi carries a warning Baqsimi carries a warning that is should be used with caution by those who have been fasting for long periods, have an adrenal insufficiency, or have chronic hypoglycemia caused by low levels of releasable glucose in the liver.

The most common adverse reactions associated with Baqsimi are nausea, vomiting, headache, upper respiratory tract irritation, watery eyes, redness of eyes and itchiness. Adverse reactions of Baqsimi are similar to that of injectable glycogen, with the addition of nasal and eye-related symptoms — the FDA release noted this was due to the way the drug is administered. 



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