FDA grants orphan status to AmideBio drug

BOULDER — The U.S. Food and Drug Administration Office of Orphan Products Development has granted Boulder-based biopharmaceutical company AmideBio LLC an orphan drug designation for its treatment of a rare genetic disorder that affects newborns and infants. 

The drug is AmideBio’s glucagon analog (ABG-023) for the treatment of congenital hyperinsulinism, a disease that causes individuals to have abnormally high levels of insulin. The disease can result in hypoglycemia, which can lead to serious neurological complications including seizures and brain damage.

The FDA orphan drug designation or status is granted to sponsors of drugs that treat rare…