Nasal Powder Glucagon Receives FDA Approval

The FDA has granted Eli Lilly and Company approval for its nasal powder glucagon (Baqsimi) for emergency treatment of severe hypoglycemia.

Severe hypoglycemia occurs when a patient's blood sugar levels fall to a level where they become confused, unconscious, or have other symptoms that require assistance from another person. It typically occurs in people with diabetes who are using insulin treatment.

While injectable glucagon has been approved in the United States for several decades, Lilly's nasal powder glucagon is the first non-injection powder. It does not require inhalation to work, only application inside the nose.

"People who are living with diabetes are at risk of their blood sugar levels falling below the normal range," said Janet Woodcock, MD, director of the FDA Center for Drug Evaluation and Research, in a prepared statement. "There are many products on the market for those who need insulin, but until now, people suffering from a severe hypoglycemic episode had to be treated with a glucagon injection that first had to be mixed in a several-step process."

Woodcock added that the new nasal powder will streamline the process for treating a severe hypoglycemic episode.

The newly approved product will be available in a single-use dispenser. It increases blood sugar levels in the body by stimulating the liver to release stored glucose into the bloodstream—the opposite effect of insulin, which lowers blood sugar levels.

The efficacy and safety of nasal powder glucagon on severe hypoglycemia was evaluated in 2 studies of 83 and 70 adults with diabetes, in which a single dose of this nasal treatment was compared to a single dose of glucagon injection. Nasal powder glucagon was shown to adequately increased blood sugar levels in the studies.

In a pediatric study of 48 patients over the age of 4 years with type 1 diabetes, similar results were observed. Nasal powder glucagon is also approved to treat severe hypoglycemia in patients ages 4 years and older with diabetes.

Lilly's nasal powder glucagon carries a warning that it should be used with caution by people who have been fasting for long periods, have adrenal insufficiency, or have chronic hypoglycemia, because those conditions result in low levels of releasable glucose in the liver.

The most common adverse reactions include nausea, vomiting, and headache, all of which are also common in injectable glucagon. Unlike injectable glucagon, upper respiratory tract irritation and eye irritation were also noted, as a result of the application to the nose.

Reference

FDA approves first treatment for severe hypoglycemia that can be administered without an injection [news release]. Silver Spring, MD; July 24, 2019: FDA website. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-severe-hypoglycemia-can-be-administered-without-injection. Accessed July 2019.