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 conditions and diseases. According to the FDA, “Orphan designation qualifies the sponsor of the drug for various development incentives of the FDA, including tax credits for qualified clinical testing.”

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“This orphan drug designation is an important step for Amidebio’s development of ABG-023 and for congenital hyperinsulinism patients and their parents. Glucagon has been shown to be a potentially game-changing treatment for these patients if it can be more readily administered, including for use in pumps,” said Pawel Fludzinski, CEO and president of AmideBio, in a written statement. “Our initial studies of ABG-023 have shown it to have great promise in overcoming the shortfalls of glucagon without sacrificing efficacy. This designation will serve to accelerate our development efforts.”