FDA OKs First-Ever Nasal Glucagon for Severe Hypos in Diabetes

Miriam E. Tucker

Disclosures

July 25, 2019

The US Food and Drug Administration (FDA) has approved the first nasally administered glucagon product (Baqsimi, Eli Lilly and Co) for the treatment of severe hypoglycemia for patients aged 4 years or older who have diabetes.

The nasal powder is the first licensed glucagon product that is not delivered by injection and that does not require a multistep mixing process.

"This new way to administer glucagon may simplify the process, which can be critical during an episode [of hypoglycemia], 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," said Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, in a statement.

Lilly said in a press release: "Baqsimi is the first and only nasally administered glucagon, and it was designed with severe hypoglycemia rescue in mind. It is compact, portable and ready to use (no reconstitution required) in a single, fixed, 3 mg dose."

The company said it plans to market the new agent at the same price as its current glucagon injection. The US list price for a Baqsimi is $280.80 for a one-pack and $561.60 for a two-pack. The company said it is "in discussions with insurance providers to make Baqsimi available to as many people as possible.

"Eligible commercially insured people with diabetes can pay as little as $25 for up to two Baqsimi devices (1 two-pack or 2 one-packs) if they use [the Lilly] savings card. This prescription is generally filled on an annual basis," the company noted.

"Lilly may also be able to help people who don't have commercial insurance coverage with options found through the Lilly Diabetes Solutions Center when Baqsimi is available in US pharmacies," which is expected to be in about a month, the company said.

Product Should Be Much Easier to Use Than Injection

The approval was based on data from three studies of people with type 1 diabetes. One study involved 70 adults, one involved 83 adults, and another involved 48 children aged 4 years or older.

The nasal formulation generally worked as well as injected glucagon in reversing insulin-induced hypoglycemia, with no major safety problems.

The new product, which comes in a single-use dispenser, is advantageous because it does not require injection of syringe contents into a vial, mixing, and drawing the solution back into the syringe prior to injecting into the patient, a process that can be daunting and can lead to errors when performed by nonmedical people in emergency situations.

According to the FDA, nasal glucagon should not be given to people with pheochromocytoma or insulinoma. Owing to the drug's mechanism of action — it stimulates release of glucose from the liver — the label will carry a warning about use in individuals with diminished capacity for hepatic glucose release, including those who have been fasting for long periods, have adrenal insufficiency, or have chronic hypoglycemia.

The most common adverse reactions associated with nasal glucagon are similar to those of injected glucagon and include nausea, vomiting, and headache. Because of the nasal mode of administration, it can also cause watery eyes and nasal congestion.

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