For Instant Release:
24. July 2019

Today, the US Food and Drug Administration approved Baqsimi nasal powder, the first glucagon treatment approved for acute treatment of severe hypoglycaemia that can be administered without injection. [19659004] Serious hypoglycaemia occurs when the patient's blood sugar level falls to a level where he or she becomes confused or unconscious or suffers from other symptoms that require the help of another person to treat. In general, severe hypoglycaemia occurs in people with diabetes taking insulin therapy. Baqsimi is approved to treat severe hypoglycaemia in patients with diabetes over four years.

"People who live with diabetes risk their blood sugar levels falling below the normal range. There are many products on the market for those who need insulin, but so far, people suffering from a severe hypoglycemic episode have to be treated with a glucagon injection which first had to be mixed in a multi-step process, ”said Janet Woodcock, MD, director of the FDAs Center. for Drug Evaluation and Research. "This new way of administering glucagon can simplify the process, which can be critical during an episode, especially since the patient may have lost consciousness or may have a seizure. In these situations, we want the process of treating the sufferer to be so simple as possible. ”

Baqsimi, a powder administered in the nose, will come in a disposable dispenser that can be given to someone suffering from a severe hypoglycemic episode. Baqsimi increases the blood sugar level in the body by stimulating the liver to release stored Glucose in the bloodstream It has the opposite effect of insulin, which lowers blood sugar levels

Injectable glucagon has been approved for use in the United States for decades The efficacy and safety of Baqsimi nasal powder glucagon for treating severe hypoglycaemia were evaluated in two studies of 83 and t 70 adults with diabetes and compared a single dose of Baqsimi with a single dose of glucagon injection to cause a blood glucose response to insulin inducers t hypoglycaemia, Baqsimi increased blood sugar levels sufficiently. In a pediatric study of 48 patients over four years of type 1

diabetes, similar results were observed.

Baqsimi should not be taken by patients with pheochromocytoma, a rare tumor of the adrenal glands or of patients who have insulinoma, a tumor of the pancreas. Baqsimi should not be taken by patients with known hypersensitivity to glucagon or the inactive ingredients found in Baqsimi, as allergic reactions may occur. Baqsimi also has a warning that it should be used with caution by those who have been fasting for extended periods, have adrenal insufficiency or have chronic hypoglycaemia because these conditions result in low levels of soluble glucose in the liver. The most common side effects associated with Baqsimi are nausea, vomiting, headache, upper respiratory irritation, watery eyes, redness of the eyes and itching. Side effects of Baqsimi are similar to injectable glucagon, with the addition of nasal and ocular related symptoms, such as watery eyes and nasal congestion, due to the way the medicine is administered.

The FDA approved Baqsimi for Eli Lilly and Company.

The FDA, an agency of the US Department of Health and Human Services, protects public health by ensuring the safety, effectiveness, and safety of human and veterinary medicines, vaccines and other biological products for humans, and medical devices. The Agency is also responsible for the safety and security of the country's food supply, cosmetics, dietary supplements, products that emit electronic radiation and for the regulation of tobacco products.

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