For immediate release:
24. July 2019

The US Food and Drug Administration approved today baqsimi nose powder, the first glucagon drug approved for the emergency treatment of severe hypoglycaemia, which can be administered without injection. [19659004] Severe hypoglycaemia occurs when a patient's blood sugar level drops to the point of becoming confused, unconscious, or experiencing other symptoms that require the assistance of another person. Typically, severe hypoglycaemia occurs in people with diabetes who use insulin treatment. Baqsimi is approved for the treatment of severe hypoglycaemia in patients with diabetes over four years.

"In people with diabetes there is a risk that the blood sugar level falls below the normal range. There are many products on the market for those who need insulin, but until now, people suffering from severe hypoglycaemia had to be treated with a glucagon injection that had to be mixed first in a multi-step procedure, "said Janet Woodcock. MD, Director of the FDA Center for Drug Evaluation and Research. "This new way of administering glucagon can simplify the process, which can be critical during an episode, especially as the patient may have lost consciousness or have a seizure. In such situations, we want the process to treat the sufferer as simple as possible. "

Baqsimi, a nasal powder, is supplied in a disposable dispenser that can be delivered to sufferers from a severe hypoglycemic episode. Baqsimi increases blood sugar levels in the body by stimulating the liver to release stored glucose into the bloodstream. It has the opposite effect of insulin, which lowers blood sugar levels.

Injectable glucagon has been approved for several decades in the United States. The efficacy and safety of Baqsimi nasal powder glucagon for the treatment of severe hypoglycemia was investigated in two studies of 83 and 70 adults with diabetes compared a single dose of baqsimi with a single dose of a glucagon injection to a blood sugar response to insulin-induced hypoglycemia trigger. Baqsimi increased the blood sugar level appropriately. Similar results were observed in a pediatric study in 48 patients over four years of type 1

diabetes.

Baqsimi should not be used in patients with pheochromocytoma, a rare adrenal tumor, or in patients with insulinoma. a tumor of the pancreas. Baqsimi must not be taken by patients with known hypersensitivity to glucagon or the inactive ingredients of baqsimi, as allergic reactions may occur. Baqsimi is also cautioned that it should be used with caution by patients with long-term fasting, adrenal insufficiency or chronic hypoglycaemia, as these conditions result in low levels of releasable glucose in the liver. The most common side effects with Baqsimi are nausea, vomiting, headache, upper respiratory tract irritation, watery eyes, redness and itching. The side effects of Baqsimi are similar to those of injectable glucagon, in addition to nasal and ocular symptoms such as watery eyes and a congested nose due to the way the medicine is used.

The FDA granted Eli approval from Baqsimi Lilly and Company.

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

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