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Xeris Pharmaceuticals Inc. announced Tuesday that the U.S. Food and Drug Administration has approved Gwalk (gluatic glucin) for the treatment of severe hypoglycemia in children and adults 2 years of age and older with diabetes. According to the company, Gvoke is the first U.S.-approved gluatic hyperglycemia product that can be given by pre-filled syringes or auto-injectors, "significantly reducing the steps taken to prepare and administration of gluatic glugemics at severe hypoglycemia." Paul Eddick, chief executive of
, said: "We are actively preparing to introduce two different management options to suit the community's preferences, starting with pre-charged syringes in four to six weeks and auto-injectors in 2020." Xeris said it plans to match the price of both versions of Gvoke with the current price of glucreatic glucemic products.
This approval is supported by phase III study data that evaluated Gvoke and conventional gluaticoicose first aid kits as treatments for severe hypoglycemia in children and adults with type 1 diabetes.
showed a 100 percent success rate for children and 99 percent for adult patients, according to Xeris, a research group. It added that usability studies have shown that pre-charged syringes and lysocemic fructose also have a nearly 100% success rate in using a simple two-step process to use full doses of glucosin.
In June, the Food and Drug Administration extended the review of Xeris' application for three months after receiving additional information from drugmakers.
also recently reported positive results from a phase III non-despicable study that compared Gvoke auto-injectors in adults with type 1 diabetes to novotin (glucemic glucemic) subsoil syringes in Novo Nord and said it would use the findings to support EU market recognition of its products.Meanwhile, in July, the U.S. Food and Drug Administration authorized Lilly's Basquimi as the first nasal-based anti-glucagoglycline preparation in the United States to treat severe hypoglycemia in people 4 years of age and older with diabetes.
price for the treatment is $280.80 for one package and $561.60 for two packs. （cyy123.com）
