Posted by Michael Wonder on 20 Aug 2020
U.S. FDA grants rare paediatric disease designation to AmideBio’s glucagon analog for the treatment of congenital hyperinsulinism
20 August 2020 - AmideBio announced today that the US FDA Offices of Pediatric Therapeutics and Orphan Products Development granted a rare pediatric disease designation to AmideBio’s glucagon analog (AB‐ G023) for the treatment of congenital hyperinsulinism.
AB‐G023 is a solution stable, soluble glucagon analog designed to overcome the limitations of glucagon – an effective treatment for congenital hyperinsulinism, but rendered impractical for long term administration given its instability in solution.
The development of AB‐G023 was funded through Small Business Innovation Research (SBIR) Phase I and II grants from the National Institute of Diabetes and Digestive and Kidney Diseases Division of the National Institutes of Health. It was granted Orphan Drug designation in April of this year.
