Zealand Pharma A/S, a biotechnology company focused on peptide-based therapeutics, announced today that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for Part 1 of its New Drug Application (NDA) for dasiglucagon. Dasiglucagon is being developed for the prevention and treatment of hypoglycemia in pediatric patients with congenital hyperinsulinism (CHI).  
 
The FDA’s decision to issue a CRL was primarily due to an ongoing inspection of a third-party contract manufacturing facility. While the facility has addressed previous deficiencies, the FDA is still evaluating the recent reinspection.
 
Despite the setback, Zealand Pharma remains committed to bringing dasiglucagon to market. The company emphasized that the FDA did not raise any concerns about the clinical data or safety profile of the drug.
 
“We at Zealand Pharma are acutely aware of the significant unmet medical need for newborns and children with congenital hyperinsulinism who have either no or very limited treatment options today,” said David Kendall, M.D., Chief Medical Officer of Zealand Pharma. “We are committed to working with the FDA and our third-party manufacturing partner to bring dasiglucagon to patients living with this devastating disease in the months ahead.”
 
In addition to the CRL, the FDA has requested additional analyses from existing continuous glucose monitoring (CGM) datasets to support the use of dasiglucagon in CHI beyond 3 weeks. Zealand Pharma expects to submit these data by the end of 2024.