Nasal glucagon baqsimi approved by the fda

WRITTEN BY: Jordan Dakin

Editor’s Note: this is a breaking news story that will be updated as additional information becomes available.

On July 24, the FDA approved Baqsimi, the first non-injectable emergency treatment for severe episodes of hypoglycemia. Submitted for approval by Eli Lilly and Company, this powder form of glucagon is administered into the nose, and comes in a single-use dispenser.

Once administered, Baqsimi works to rapidly increase blood glucose levels by stimulating the liver to release accumulated glucose into the bloodstream.

Glucagon is the standard treatment in situations of severe hypoglycemia, but until now, all approved treatments have come in the form of an injection. Injectable glucagon has been available for several decades, but is not shelf-stable at room temperature and therefore requires mixing a powder and liquid with a syringe, which can be intimidating and prone to user error in emergency situations.

“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,” said Janet Woodcock, M.D., Director of the FDA’s Center for Drug Evaluation and Research.

Baqsimi was evaluated in two studies of 83 and 70 adults with diabetes respectively, during which a single dose of the nasal powder was compared to a single dose of glucagon injection. The FDA reported that Baqsimi was satisfactory in increasing blood glucose levels. A pediatric study of 48 patients with Type 1 diabetes also saw similar results.

Notably, Baqsimi does not need to be inhaled and therefore can be administered to an unconscious person suffering from severe hypoglycemia.

“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,” added Woodcock, M.D.

Baqsimi should be available in U.S. pharmacies within a month. The U.S. list price for a Baqsimi one-pack will be $280.80, which is the same price as injectable glucagon. Beyond Type 2 is hopeful the new drug is expected to be widely covered by all insurance plans that currently cover injectable glucagon.

“This FDA approval demonstrates our ongoing commitment to help people with diabetes,” said Dr. Sherry Martin, Vice President of Lilly Medical Affairs. “We believe this new treatment option is an important innovation for people with diabetes and those close to them.”

Read the full press release from the FDA here.

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The most common adverse reactions associated with Baqsimi are nausea, vomiting, headache, upper respiratory tract irritation, watery eyes, redness of eyes and itchiness.

Even with the side-effects, probably preferable to visiting the ER

Medicare only partially covers the cost of Glucagon, an overly-expensive medication, IMO.
The nasal delivery sounds promising.

OTOH, if it works it could stop a seizure or death…so there’s that. :slight_smile:

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The $280US sounds steep for those who pay out of pocket. I wonder what the Canadian price will be when Health Canada gets around to approving it?

Yeah, then there’s that. Seizures and death do suck …

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Even if insurance doesn’t cover it, as long as the shelf life is reasonably (1 year +), it’s probably worth the price to keep one around.

For what I’ve been charged, coupled with the fact I haven’t used Glucagon since the early 1990’s I don’t consider just one-year shelf-life to be acceptable. Usually the expiration is greater than a year, so periodically I’ll buy one “just in case”. I only take them on vacations–I don’t keep them handy around town. They sit in my “stash” drawer.

I love the idea of how easy it is to use, and should be pretty easy to use by just about anyone.
I know my wife absolutely hated the idea of having to mix anything for a shot.
And lets face it, if you are having seizures, giving a shot is NOT easy! And while Nasal would still be a challange in this situation, it would seem far easier.

Yup. Some people have a pretty rough time with Glucagon too.

I mean, all pharmaceutical names sound like something from Lewis Carrol, but Baqsimi? That’s what they’re going with? Oh frabjous day.

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Check a few of the newly-coined drug names—Incivek, Adcetris, Yervoy, Viibryd, Zytiga, Xgeva.
also: Farxiga. Hetlioz. Otezla. Zykadia.

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They lost me years ago at Ibuprofen. And my wife can’t manage to pronounce omeprazole to save her life.

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:joy_cat: whoever comes up with these names needs to be fired

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Is there going to be a more stable injectable version? I heard there was. As an asthmatic with sinus issues I don’t want to put irritating powder in my nose.

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