From Nasdaq:



Zealand Pharma A/S has received a Complete Response Letter from the FDA for Part 1 of the NDA for dasiglucagon for the treatment of hypoglycemia in pediatric patients with congenital hyperinsulinism. This is due to deficiencies identified in a third-party manufacturing facility, and not due to concerns about the drug’s clinical data or safety. Zealand plans to resubmit the NDA in the first half of 2024, pending a successful reinspection of the manufacturing facility. The FDA had granted Priority Review for up to three weeks of dosing, and the regulatory review of dasiglucagon is planned to be conducted in two parts. The drug is being developed for the treatment of congenital hyperinsulinism, a severe and rare genetic disease affecting infants and children. Zealand is also working on providing additional analysis from existing continuous glucose monitoring datasets, as requested by the FDA. Overall, the company still expects to move forward with the NDA process, albeit with a delay.



Original: ZEAL : FDA Issues CRL For Dasiglucagon In Congenital Hyperinsulinism For Up To 3 Weeks Of Dosing