The company’s product is designed to treat severe hypoglycemia in people with diabetes. The FDA is slated to make a decision about Xeris’ pen by June 10, 2019.
“The FDA acceptance of our NDA for review is an important milestone for Xeris. If approved, the Xeris glucagon rescue pen would be the first ready-to-use, liquid-stable glucagon in an auto-injector to treat severe hypoglycemia. Compared to the current glucagon rescue option for people with diabetes who are at risk for severe hypoglycemia, the Xeris glucagon rescue pen would eliminate the need for reconstitution and dramatically simplify the preparation and administration process,” Xeris chairman & CEO Paul Edick said in prepared remarks. “We believe that our glucagon rescue pen has the potential to make an important difference in the lives of people with diabetes.”
Xeris’s application, submitted via a 505(b)2 process, was supported by data from multiple Phase III trials of the glucagon pen auto-injector. The company compared its device to glucagon emergency kits that are already on the market and found that its auto-injector performed well against competitive products.
In August, Xeris launched a Phase I trial of its ready-to-use liquid glucagon in a closed-loop, dual-hormone artificial pancreas system.
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