US FDA declines to approve Zealand Pharma’s drug for low blood sugar in Infants, ET HealthWorld

December 24, 2023 Staff Reporter 772 Views 0 Comments

New Zealand: The U.S. Food and Drug Administration (FDA) declined to approve Zealand Pharma’s drug for the prevention and treatment of low blood sugar in children with a genetic disorder, the drugmaker said on Saturday.

The company said the FDA raised concerns about deficiencies it found at a third-party manufacturing facility following an inspection.

Zealand Pharma said that the agency did not directly raise any concerns regarding the clinical data package or safety of dasiglucagon, the drug it plans to use in patients with congenital hyperinsulinism (CHI).

The company is seeking regulatory approval for the use of the drug in patients aged seven days or older with CHI, a genetic disorder in which the insulin cells of the pancreas secrete too much insulin.

It now expects to reapply for approval of the drug in the first half of 2024 to use it for up to three weeks of dosing soon after it completes a successful re-inspection of the third-party manufacturing facility.