This article is more than 5 years old. Information may no longer be current.
Soluble glucagon granted orphan drug status for hypoglycemia prevention
Click Here to Manage Email Alerts
The FDA granted orphan drug designation to Xeris Pharmaceuticals for its soluble glucagon, according to a company press release.
The drug will be used for the prevention of severe, persistent hypoglycemia in patients with congenital hyperinsulinism.
The European Commission also granted orphan drug designation after a recommendation from the European Medicine Agency’s (EMA) Committee for Orphan Medicinal Products.
“We are pleased that both the FDA and EMA have recognized the importance of [congenital hyperinsulinism] and designated orphan status for our soluble glucagon product for this indication,” Douglas R. Baum, CEO of Xeris Pharmaceuticals, said in the release. “Covered by multiple US investigational new drug applications, we are developing several soluble glucagon products for patients with diabetes, we believe our glucagon can be useful in a number of other patient populations, such as the [congenital hyperinsulinism] population, who suffer from severe, persistent hypoglycemia.”