FDA Approves First-Ever Liquid, Temperature-Stable Glucagon – Diabetes Daily

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Just a few weeks ago, we reported on the pipeline of products from Xeris Pharmaceuticals, which include an array of ready-to-use, liquid, temperature-stable glucagon products.

Excitingly, the company just announced in a press release earlier today, that their glucagon injectable, GVOKE, received FDA approval. GVOKE will be available as either a pre-filled syringe (GVOKE PFS) as well as an autoinjector pen (GVOKE HypoPen). The products are approved for the treatment of severe hypoglycemia for patients ages two and older and are indicated to deliver a single dose of the medicine.

As per today’s press release,

GVOKE is the first glucagon product approved that can be administered via a prefilled syringe (GVOKE PFS) or auto-injector (GVOKE HypoPen™), vastly reducing the steps to prepare and administer glucagon in the event of severe hypoglycemia, or dangerously low blood sugar levels. These innovative formats are designed to provide the reliability of a ready-to-use liquid glucagon while making it easier for patients or caregivers to administer quickly and simply. GVOKE will be available in two doses: a 0.5 mg/0.1 mL dose for pediatric patients and a 1 mg/0.2 mL dose for adolescent and adult patients. GVOKE is contraindicated in patients with pheochromocytoma, insulinoma, and patients with a known hypersensitivity to glucagon or to any of the excipients in GVOKE.

Clinical trials on the new products demonstrated excellent efficacy, with 99% of adult and 100% of pediatric patients successfully treated, with minor side effects, similar to those typically seen with the previously-available glucagon kit that requires reconstitution.

The announcement of this approval is a very exciting development for patients with diabetes, as it can allow for a more straightforward and timely treatment of severe hypoglycemia in an emergency situation.

Aaron J. Kowalski, Ph.D., President and CEO of JDRF, had this to say about the product approval,

The approval of GVOKE is an important step forward for people with diabetes. Severe hypoglycemia is a terrifying and dangerous diabetes complication. This new option will make treatment easier and faster in the event of an emergency.

The company expects that the pre-filled pen will become available in as few as 4-6 weeks, while they expect to bring the autoinjector pen to market in 2020.

You can learn more about this news by accessing the press release.

Please stay tuned as we continue to bring you more updates on these exciting developments.

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