FDA, EMA Grant Orphan Drug Designation To Xeris' Soluble Glucagon
By Cyndi Root
Xeris Pharmaceuticals announced in a press release that the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) has granted Orphan Drug designation to its soluble glucagon. The investigational new drug shows promise in the prevention of severe, persistent hypoglycemia in patients with congenital hyperinsulinism (HI).
Douglas R. Baum, Xeris' CEO, said, "We are pleased that both the FDA and EMA have recognized the importance of HI and designated orphan status for our soluble glucagon product for this indication."
Soluble Glucagon
Xeris’ soluble glucagon formulation is a pump-delivered glucagon product administered continuously to prevent high insulin levels and severe hypoglycemia. Mr. Baum stated that Xeris is developing several soluble glucagon products for numerous patient populations, including those with diabetes. The pancreas secretes glucagon, a metabolic hormone that raises blood glucose levels through a conversion of glycogen to glucose. HI patients have genetic defects that cause the pancreas to overexpress insulin causing hypoglycemia (low blood glucose). In severe cases, the hypoglycemia can cause coma, seizures, brain injury, and death.
The Executive Director of Congenital Hyperinsulinism International (CHI), Julie Raskin, commented on the Orphan Drug status. She said, "CHI is very optimistic about the potential for Xeris' glucagon, particularly in the medical management of the diffuse form of HI which affects all the cells in the pancreas." She said that current treatments include removing most of the pancreas, however this process leaves patients insulin-dependent for the rest of their lives.
About Xeris
Xeris Pharmaceuticals develops injectable therapeutics for multiple indications. Formulations include non-aqueous, subcutaneous, and intradermal delivery of peptides, proteins, antibodies, and small molecules.
In April 2014, Xeris announced that it had been granted a U.S. patent (No. 8,697,644), “Stable Formulations for Parenteral Injection of Peptide Drugs.” The patented technology is a method of formulating aqueous peptides in concentrated, non-aqueous solutions, allowing health care providers to directly inject the product without taking the time to reconstitute them — an advantage in emergency situations. Xeris states that it intends to advance the method and apply it to auto-injectors, pens, and pumps.