FDA Delays Approval of Zealand Pharma’s Dasiglucagon for Congenital Hyperinsulinism Due to Third-Party Manufacturing Issues

FDA Decision:
The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for Zealand Pharma's dasiglucagon, a treatment for congenital hyperinsulinism (CHI) in pediatric patients 7 days of age and older for up to 3 weeks of dosing.

Reason for Delay:
The CRL is related to the timing of a re-inspection at a third-party contract manufacturing facility that was completed in August/September 2024. The facility has not yet received its inspection classification following the re-inspection.

No Clinical Concerns:
The CRL did not state any concerns about the clinical data package or safety of dasiglucagon.

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

Additional Data Requested:
The FDA requested additional analyses from existing continuous glucose monitoring (CGM) datasets from the Phase 3 clinical program to support the use of dasiglucagon in CHI beyond 3 weeks. Zealand expects to submit these data by the end of 2024.

Unmet Medical Need:
Congenital hyperinsulinism is a severe, ultra-rare genetic disease with significant unmet medical need for more and better treatment options. Current treatments have limitations and can be associated with serious side effects.