Zealand’s Hypoglycemia Drug Faces Second FDA Rejection Due to Manufacturing Issues

FDA Rejection:
The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Zealand Pharma for its drug dasiglucagon, intended for the treatment of congenital hyperinsulinism (CHI) in pediatric patients.

Reason for Rejection:
The rejection is related to the timing of the FDA's reinspection of Zealand's third-party contract manufacturing facility, which previously had deficiencies. The reinspection was completed in August/September 2024, but the facility has not yet received its new inspection classification.

Clinical Data:
The CRL did not state any concerns about the clinical data package or safety of dasiglucagon. The FDA requested additional analyses from existing continuous glucose monitoring (CGM) datasets for use beyond 3 weeks, which Zealand expects to submit by the end of 2024.

Regulatory Review: The regulatory review of dasiglucagon is being conducted in two parts under the same New Drug Application (NDA):
Part 1 for dosing up to 3 weeks and Part 2 for use beyond 3 weeks.

Disease Background:
Congenital hyperinsulinism (CHI) is a severe, ultra-rare genetic disease primarily affecting infants and children, leading to frequent, recurrent, and often severe episodes of hypoglycemia. Current treatments have significant limitations, highlighting a need for new and better treatment options.

Previous Approval:
Dasiglucagon was previously approved by the FDA in 2021 as Zegalogue for the treatment of severe hypoglycemia in diabetes patients.