FDA approves Xeris ready-to-use glutagon Gvoke injection application

recently, Xeris Pharmaceuticals announced thatFDA(http://approved its application for a market application for a ready-to-use glucagon Gvoke injection to treat severe hypoglycemiaGvoke has two application devices, the pre-filled needle GvokePFS and the lifesaving pen GvokeHypoPen, for use in children over 2 years of age as well as adult patientsAbout the Gvoke injectionXeris Gvoke injection is also a ready-to-use and self-help type of glucagon application deviceXeris' proprietary formulation technologies, XeriSol™ and XeriJect™, use non-proton polar solvents in non-water phases, and use biocompatible thinner "wetting" powders to produce ultra-concentrated, low-volume paste formulationsBoth small and biological macromolecules (proteins, antibodies, vaccines) are formulated for high stability and solubility for muscle or subcutaneous injectionXeris' proprietary formulation technology overcomes the low stability of traditional formulations (requiring refrigeration, liquid diluent reconstruction) and low solubility (requires complex solubility steps, large injection doses) where XeriJect ™ to biomoleculars to achieve more than 400 mg/ml solubility, while traditional formulations have a solubility range of 50-250 mg/mlFDA approval is based on the results of three critical Phase 3trial(http://These trials have demonstrated the effectiveness and safety, and usefulness, of Gvoke's treatment of patients with hypoglycemia caused by type 1 diabetes