FDA approves Xeris ready-to-use glutagon Gvoke injection application
-
Last Update: 2020-06-08
-
Source: Internet
-
Author: User
Search more information of high quality chemicals, good prices and reliable suppliers, visit
www.echemi.com
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
This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only.
This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of
the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed
description of the concern or complaint, to
service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content
will be removed immediately.
