Complete Response for dasiglucagon to provide prevention and treatment of hypoglycemia in pediatric patients. Novo Nordisk + Zealand Pharma A/S
Zealand Pharma A/S announced that the FDA has issued a Complete Response Letter (CRL) for Part 1 of the New Drug Application (NDA) for dasiglucagon for the prevention and treatment of hypoglycemia in pediatric patients 7 days of age and older with congenital hyperinsulinism (CHI) for up to 3 weeks of dosing
The CRL is related to deficiencies identified following an inspection at a third-party contract manufacturing facility. These deficiencies are not specific to dasiglucagon. The CRL did not state any concerns about the clinical data package or safety of dasiglucagon.
Zealand expects to resubmit the NDA for dasiglucagon for CHI for up to three weeks of dosing in the first half of 2024 contingent on successful reinspection of the third-party manufacturing facility.
The FDA granted dasiglucagon Priority Review on August 30, 2023 for up to three weeks of dosing. The regulatory review of dasiglucagon is planned to be conducted in two parts under the same NDA. Part 1 relates to dosing of up to 3 weeks and Part 2 relates to the use beyond 3 weeks. Supporting the use of dasiglucagon in CHI beyond 3 weeks, the FDA requested additional analyses from existing continuous glucose monitoring (CGM) datasets, which Zealand still expects to submit in the first half of 2024. CGM was included as a secondary outcome measure in the Phase III clinical program.
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