FDA Grants Orphan Drug Designation for Treatment of Congenital Hyperinsulinism

The U.S. Food and Drug Administration has granted orphan drug designation to glucagon analog (ABG-023) for the treatment of congenital hyperinsulinism (CHI).

“This orphan drug designation is an important step for AmideBio’s development of ABG-023 and for CHI 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 press release. “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.”  

Read the full press release here.

Source: AmideBio LLC