FDA rejects Zealand Pharma hypoglycemia drug over manufacturing reinspection

Zealand Pharma has received a Complete Response Letter (CRL) from the U.S. FDA for dasiglucagon, intended to treat hypoglycemia in children with congenital hyperinsulinism (CHI). 

The CRL is linked to the reinspection of a third-party manufacturing facility, completed in August/September 2024, for which the classification is still pending. The clinical data and safety of dasiglucagon were not cited as concerns.

The CRL affects Part 1 of the New Drug Application (NDA), which covers dosing for up to three weeks. Zealand Pharma is working with the FDA and the manufacturer to resolve the reinspection issue. The company plans to submit additional data for Part 2 of the NDA, which supports dasiglucagon's use beyond three weeks, by the end of 2024.

Congenital hyperinsulinism is a rare genetic disorder affecting infants and children, leading to severe episodes of hypoglycemia. Current treatment options are limited, with many patients not responding adequately to available therapies.