Zealand Pharma Receives FDA CRL for Pediatric Dasiglucagon

Zealand Pharma A/S, a biotech company specializing in peptide-based drugs, revealed that the FDA has issued a Complete Response Letter (CRL) for Part 1 of the NDA for dasiglucagon for treating hypoglycemia in children with CHI.

The CRL is connected to the scheduling of a follow-up inspection at a third-party contract manufacturing facility that finished in August/September 2024. The third-party manufacturer is still awaiting their inspection designation after the reinspection. An earlier evaluation of the building had uncovered issues unrelated to dasiglucagon. These previous shortcomings were addressed during this reevaluation. The CRL did not raise any issues regarding the clinical data package or safety of dasiglucagon.

The evaluation of dasiglucagon by regulators is divided into two sections within the same New Drug Application process. Part 1 is about dosing for a maximum of 3 weeks, while Part 2 is about using the medication for longer than 3 weeks. The FDA asked for more analysis of CGM data from the Phase 3 clinical program to support the use of dasiglucagon in CHI for more than 3 weeks. Zealand plans to deliver this information by the conclusion of 2024.

“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.”