FDA grants rare disease drug status to AmideBio’s pediatric hyperinsulinism treatment

BOULDER — The U.S. Food and Drug Administration granted a rare pediatric disease designation to diabetes drug developer AmideBio LLC.

The Boulder-based AmideBio received the designation for its AB-G023 drug candidate, a genetic treatment for hyperinsulinism in children. With the designation, the company would receive a voucher for priority review of a different drug if AB-G023 is approved for sale, which the company could use for another drug in its development pipeline or sell to a different firm.

Hyperinsulinism occurs when a patient’s pancreas overproduces insulin and causes low blood sugar, or the opposite effect of…