-Craig Idlebrook and Dan Pereira
Xeris Pharmaceuticals announced today that it has received FDA approval to bring GVOKE, the first room-temperature-stable injectable glucagon, to the U.S. market. GVOKE will be available in pre-filled syringes and as an autoinjector, and can be used to treat hypoglycemia in people with diabetes, ages 2 and up.
The decision has been long anticipated. In August 2018, Xeris first submitted its novel glucagon formulation for approval, but the FDA sent notice in June 2019 that it would delay a decision on the drug. Xeris has been developing its line of room-temperature-stable glucagon products for more than five years.
The approval comes after the positive results from three Phase 3 clinical trials, which showed a 100% rate of success with the product in the treatment of severe hypoglycemia in children, and a 99% success rate in the treatment of adults, according to a press release from Xeris.
This is the second ready-to-use glucagon to receive FDA approval this summer. In July 2019, Eli Lilly and Company announced FDA approval for Baqsimi, a nasally-administered glucagon that was originally developed by Locemia Solutions.
The approval of these two glucagons might signal the beginning of the end of the market share for glucagon injectable products currently on the market, which must be mixed before use. The additional steps required for such glucagon may lead some to forgo using emergency glucagon, and instead call 911 for those who are experiencing severe hypoglycemia. Such a delay in treatment can lead to worse medical outcomes for hypoglycemia.
A recent T1D Exchange Patient-Centered Research study revealed that just 68 percent of adults with type 1 diabetes said they had a current glucagon prescription. The researchers also discovered that just 18 percent of those who said they received an emergency injection of glucagon said that it was administered problem-free.
9/10/2019 – 1:00 pm – A previous version of this article erroneously said that the other injectable glucagons on the market must be refrigerated.