On Tuesday, the type 1 diabetes (T1D) community got a helping hand in their ability to avoid severe hypoglycemia when the Food and Drug Administration (FDA) approved the first premixed, prefilled liquid glucagon formulation that can be used with either a pre-filled syringe (GVOKE PFS) or an auto-injector (GVOKE HypoPenTM). Xeris Pharmaceuticals, which created the product to treat severe hypoglycemia, gained approval after multiple clinical studies showed that the drug was safe and effective.
Hypoglycemia, or low blood sugar, is a daily concern for people with T1D. This condition happens when the body has too little food or too much insulin. Left untreated, acute hypoglycemia can cause seizures, coma and, in some cases, even death. To counteract severe hypoglycemia, a person’s body normally produces the hormone glucagon, which causes the liver to convert stored glucose into useable glucose.
However during an episode of hypoglycemia, people with T1D need glucagon right away. “Current rescue methods, including commercial glucagon kits, are ‘labor-intensive’ and require significant coordination, which a person affected by hypoglycemia is often unable to accomplish,” said Sanjoy Dutta, Ph.D., VP of Research at JDRF. Also a ready-to-use rescue glucagon such as GVOKE may indirectly lead to better long term glucose and psychosocial outcomes since people will not limit their insulin dosing due to fear of imminent or potential hypoglycemia.
“The approval of the GVOKE HypoPenTM 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, which will improve and even save lives.”Aaron J. Kowalski, Ph.D., President and CEO of JDRF
For both of these reasons, GVOKE products can be a real boost for people suffering from hypoglycemia. The ready-to-use, room-temperature stable liquid glucagon greatly reduces the steps needed to prepare and administer life-saving glucagon in an emergency.
“The approval of the GVOKE HypoPenTM is an important step forward for people with diabetes,” said Aaron J. Kowalski, Ph.D., President and CEO of JDRF. “Severe hypoglycemia is a terrifying and dangerous diabetes complication. This new option will make treatment easier and faster, which will improve and even save lives.”
The FDA’s approval was based on positive results from multiple phase III clinical trials, which exhibited the ability of GVOKE products to treat severe hypoglycemia compared with conventional glucagon emergency kits. The studies demonstrated 100% treatment success in children and 99% treatment success in adults.
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