FDA Approves Eli Lilly's Nasal Glucagon to Treat Severe Hypoglycemia Without Injection

This story has been updated with the list price of Baqsimi.

The FDA Wednesday approved Eli Lilly & Co.’s nasal glucagon, to be sold under the name Baqsimi, the first such therapy approved for the emergency treatment of severe hypoglycemia that can be administered without an injection.

Nasal glucagon is seen as a game-changing delivery method to replace the multistep system of mixing powder and liquid with a simple, 1-step spray.

The formulation is intended to shave crucial minutes and stress from the current method for delivering this hormone to people with diabetes experiencing severe hypoglycemia, which can lead to hospitalization or even death in extreme cases. Baqsimi is approved to treat severe hypoglycemia in patients with diabetes 4 and older.

Trying to mix the powdered glucagon and inject it when a person is experiencing severe hypoglycemia can be difficult, and often the person with diabetes needs assistance from a family member, friend, coworker, or teacher. In some states, schools have tried to force T1D children out of their neighborhood schools to the only school in the district with a nurse because classroom teachers and staff are unwilling to administer glucagon.

Eli Lilly said the list price for a 1-pack of Baqsimi is $280.80; a 2-pack is $561.60.

Eli Lilly, one of the 3 leading manufacturers of insulin and the leading seller of emergency glucagon kits, purchased worldwide rights to nasal glucagon developed by Locemia in October 2015.

Normally, glucagon is produced in the pancreas and works with insulin to regulate blood glucose levels in the body. Glucagon is released in the body when blood glucose levels are low, signaling the liver to release glucose into the blood. People with diabetes either no longer produce insulin (type 1) or their bodies are less able to respond to insulin (type 2). For those with type 1 diabetes (T1D), too much insulin can limit the body’s ability to release glucagon as blood glucose levels fall; thus, if the person with T1D is unable to eat or drink sugar, an injection of glucagon is needed to bring blood glucose levels back into balance.

Severe hypoglycemia occurs when a patient’s blood sugar levels fall to a level where he or she becomes confused or unconscious or suffers from other symptoms that require assistance from another person to treat. Typically, severe hypoglycemia occurs in people with diabetes who are using insulin treatment.

“People who are living with diabetes are at risk of their blood sugar levels falling below the normal range. 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,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “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. In those situations, we want the process to treat the suffering person to be as simple as possible.”

Baqsimi will come in a single-use dispenser. The efficacy and safety of Baqsimi nasal powder glucagon to treat severe hypoglycemia was evaluated in 2 studies of 83 and 70 adults with diabetes, comparing a single dose of Baqsimi to a single dose of glucagon injection in causing a blood sugar response to insulin-induced hypoglycemia. Baqsimi adequately increased blood sugar levels. Similar results were observed in a pediatric study of 48 patients over the age of 4 with T1D.

Baqsimi should not be taken by patients with pheochromocytoma, a rare tumor of adrenal gland tissue, or by patients who have insulinoma, a tumor of the pancreas. Baqsimi should not be taken by patients with a known hypersensitivity to glucagon or the inactive ingredients found in Baqsimi, as allergic reactions may occur. Baqsimi also carries a warning that it should be used with caution by those who have been fasting for long periods, have adrenal insufficiency or have chronic hypoglycemia because these conditions result in 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. Side effects of Baqsimi are similar to injectable glucagon, with the addition of nasal and eye-related symptoms, such as watery eyes and nasal congestion, because of the way the drug is administered.

“Severe hypoglycemia is an unpredictable event for people with diabetes that can happen anytime, anywhere. It’s an experience that can be very stressful and difficult for those helping a person in a low blood sugar emergency,” said Sherry Martin, MD, vice president of Lilly Medical Affairs. “The FDA’s approval of Baqsimi may help people prepare for these moments with an innovative product that has the simplicity of nasal administration