Dasiglucagon for (CHI)
Congenital hyperinsulinism (CHI) is a rare disease affecting mainly newborns and toddlers. It is caused by a defect in pancreatic .-cells, resulting in insulin overproduction. This leads to persistently and often severely low blood sugar levels (hypoglycemia).
The most severely affected children need to have their pancreas surgically removed within a few months of birth in order to prevent hypoglycemia. This invariably results in the development of type 1 diabetes.
Current treatment options are insufficient: Fewer than one-third of newborns and two-thirds of older children respond to approved medical therapy.
CHI develops in one out of 50,000 (or fewer) children. This corresponds to 180-300 children diagnosed in the U.S. and Europe every year.
Zealand is developing dasiglucagon as a potential treatment option for CHI, a rare disease affecting mainly newborns and toddlers. It is caused by a defect in the pancreatic beta cells, resulting in insulin overproduction.
In 2017, the U.S. FDA and the European Commission both granted orphan drug designation to dasiglucagon for the treatment of CHI.
The FDA's approval of Zealand's IND application allows the Company to proceed into Phase 3 development of dasiglucagon for the treatment of CHI.