The FDA has approved a new ready-to-use liquid glucagon that will be available in auto-injector rescue pen much like the EpiPen and also prefilled syringe model, bringing the Diabetes Community a potentially game-changing option for treating emergency low blood sugar episodes.
On Sept. 10, Chicago-based Xeris Pharmaceuticals received regulatory approval for its Gvoke glucagon products, filed with FDA in August 2018.
This Xeris glucagon approval comes within two months of another big breakthrough in emergency glucagon: Eli Lilly’s new nasal glucagon Baqsimi, which is absorbed into the nasal lining and begins working within minutes.
Both new products are revolutionary in that they’re the first new types of glucagon to be introduced since the existing, complicated mix-and-inject kits were introduced in 1961. Lilly launched Baqsimi (which it acquired from Canadian startup Locemia Solutions in 2015) in late August, and that’s becoming available in pharmacies across the US now.
Here’s the status on Xeris just-approved glucagon products that will be available starting in late 2019:
Why the Gvoke name? We’re told the name alludes to the many emotions that come along with severe hypogylcemia; the “G” is obviously a reference to “glucagon,” but the name’s meant to evoke feelings of relief and comfort for those facing low glucose emergency treatment. (Anyone watching this company for a while may remember the product began as the “G-Pen,” until Xeris opted for a more compelling name.)
HypoPen: Think of an EpiPen, but for diabetes hypo emergencies. This is something people with diabetes have been longing for! It’s an auto-injector containing a 6mm needle inside, but you’ll never see the needle in use as the pen is self-contained for quick one-time use and disposal. In stark contrast to today’s glucagon kits, this has an easy, two-step process to use: pull off the red cap and push the Gvoke HypoPen down on the skin for five seconds, until the window turns red. That’s it! Then the pen auto-retracts and locks so it can’t be used again.
Prefilled Syringe: This version will be prefilled with the glucagon formulation, in either a pre-measured .5 mg dose or 1 mg dose, sold pre-packaged in plastic wrap. The size is not as intimidating as it looks in some of the marketing materials. Originally, Xeris only planned to introduce a rescue pen version. But market research later revealed a desire for some patients to be able to actually see the needle, to ensure the dosage was actually injected. This version will also cost less to manufacturer, company sources tells us, which allows them to launch it quicker than the auto-injector version.
Super Fast Action:Clinical study data shows the Xeris glucagon formulation starts working within minutes, and everyone treated in studies saw glucose levels increase 20 mg/dL within a half-hour of injection. Mostly mild side effects included nausea.
One and Two Packs: Xeris plans to sell the Gvoke pens in a single package or two-packs, something especially important for those who might want to have more than one on hand, at home or at work/school, etc.
OK for Kids and Adults: Gvoke is approved for use in ages 2 and older. For both the prefilled syringe and rescue pen versions, there will be a .5 mg dose option for children and 1mg dosages for adults.
Shelf Life: Both versions will last up to 2 years at room temperature without needing refrigeration (consistent with existing glucagon products on the market). Xeris is also studying longer expiration dates.
Easy to Use: Study data by Xeris also shows that 99% of people and caregivers using Gvoke found it easy to use without any trouble, compared to existing glucagon emergency injection kits that showed only 6-31% usability success.
Mini-Dosing? Not yet. Neither of these initial first-generation glucagon products from Xeris allow for small incremental doses to raise blood sugar in non-emergency situations (aka mini-dosing), but that’s something the company says it’s working on.
Xeris says it will first launch the Prefilled Syringe (PFS) version 4-6 weeks from now in late 2019, since it’s easier and costs less to make. The HypoPen will be made by a third-party supplier and is expected in 2020. Xeris says it will now be working with insurers/payers to get coverage and formulary inclusion.
The company expects to file for approval in Europe by the end of 2019, and they’re currently seeking supply/distribution partners in the EU.
Xeris isn’t specific on actual list prices, but says only that pricing will be “in parity” with existing glucagon products on the market. If so, that translates to roughly $280 for a single Gvoke injector pen, and ~$561 for a two-pack.
Like most pharma companies, Xeris says it will also offer co-pay assistance programs and discount cards to help people afford Gvoke — both for people without health insurance and also for those with commercial insurance. Details are not yet finalized, but like with other Patient Assistance Programs, eligibility requirements are likely to be strict.
Those chiming in on this Xeris Gvoke approval are using words like “milestone.” After more than 50 years of having nothing but the traditional, complicated three-step emergency kits, this is quite the breakthrough.
For example, Jeff Hitchcock, Ohio D-Dad and founder of the Children With Diabetes organization says: “Until now, many people may have been hesitant to use conventional glucagon kits because the complex preparation felt confusing and perhaps overwhelming. With Gvoke as a new glucagon option, we gain an easy-to-use and effective solution to a dangerous and stressful event.”
However, some folks expressed disappointment on the pricing front. Making Gvoke comparable in pricing to existing glucagon products (just as Lilly has done with its new nasal Baqsimi glucagon) means that another critical, life-sustaining medication becomes unaffordable to so many with diabetes who need it.
It’s thrilling that we finally have forms of emergency glucagon that can be made readily available in places like schools, gyms, and workplaces, and in the hands of paramedics. Now the hope is that Xeris, Lilly and others can also make milestone moves on access and affordability.
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