FDA approves first treatment for severe hypoglycemia that can be administered without injection

SILVER SPRING, Md., July 24, 2019 / PRNewswire / – The US Food and Drug Administration today approved the Baqsimi Nasal Powder, the first glucagon treatment approved for the emergency treatment of lupine. severe hypoglycaemia that can be administered without

Severe hypoglycemia occurs when a patient's blood sugar drops to a level that makes him confused or unconscious or that has other symptoms requiring the badistance of another person to treat. Severe hypoglycemia usually occurs in diabetics on insulin. Baqsimi is approved to treat severe hypoglycemia in diabetic patients of four years of age and older.

"People with diabetes are at risk of falling below normal blood sugar levels.There are many products on the market for those who need insulin, but up to now, people with An episode of severe hypoglycemia had to be treated with a glucagon injection that had first to be mixed in a multi-step process, "said Janet Woodbad, MD, director of the Center for Disease Control. evaluation and research of FDA drugs. "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. that the process of treating the suffering person is as simple as possible. "

Baqsimi, a powder administered in the nose, will be presented in a disposable dispenser that can be administered to a person suffering from a severe hypoglycemia episode. Baqsimi raises blood sugar in the body by stimulating the liver so that it releases the glucose stored in the blood. It has the opposite effect of insulin, which lowers blood sugar.

Injectable glucagon has been approved in the United States for several decades. The efficacy and safety of glucagon Baqsimi nasal powder for the treatment of severe hypoglycemia have been evaluated in two studies involving 83 and 70 diabetic adults , comparing a single dose of Baqsimi to a single dose. injection of glucagon causing a glycemic response to insulin-induced hypoglycemia. Baqsimi has adequately increased blood sugar. In a pediatric study in 48 patients over four years of age with type 1 diabetes, similar results were observed.

Baqsimi should not be taken by patients with pheochromocytoma, a rare tumor of adrenal gland tissue, or by patients with insulinoma, a pancreatic tumor. Baqsimi should not be taken by patients with known hypersensitivity to glucagon or inactive ingredients contained in Baqsimi, as allergic reactions may occur. Baqsimi also warns that people who have been fasting for a long time with adrenal insufficiency or chronic hypoglycaemia should be cautious because they cause low levels of releasable glucose in the liver. The most common side effects badociated with Baqsimi are nausea, vomiting, headache, upper respiratory tract irritation, tearing, redness of the eyes, and itching. The side effects of Baqsimi are similar to those of injectable glucagon, with the addition of nasal and ocular symptoms, such as watery eyes and nasal congestion, due to the way the drug is administered.

The FDA has approved Baqsimi's approval by Eli Lilly and Company.

The FDA, an agency of the US Department of Health and Social Services, protects public health by ensuring the safety, efficacy and safety of human and veterinary drugs, vaccines and other biological products for human use and medical devices. The agency is also responsible for the safety of food products, cosmetics, dietary supplements, products emitting electronic radiation and the regulation of tobacco products.

Media requests: Nathan Arnold, 301-796-6248, [email protected]
Consumer Inquiries: 888-INFO-FDA

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SOURCE US Food and Drug Administration