The Food and Drug Administration (FDA) has granted Orphan Drug designation to ABG-023, a glucagon analog (AmideBio), for the treatment of congenital hyperinsulinism. 

Congenital hyperinsulinism (CHI) is a rare disease that affects newborns and children resulting in persistent hypoglycemia due to the overproduction of insulin. ABG-023 is a solution stable, soluble glucagon analog developed using proprietary technology to overcome the limitations of glucagon instability in solution. 

“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. “Our initial studies of ABG-023 have shown it to have great promise in overcoming the shortfalls of glucagon without sacrificing efficacy.” 

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According to the Company, the solution stable glucagon may also be potentially beneficial in the treatment of emergency hypoglycemia, such as with patients who develop hypoglycemia following bariatric surgery. 

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