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.”
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.
For more information visit amidebio.com.