Zealand Pharma announces designation of priority review by the FDA for dasiglucagon in congenital hyperinsulinism.
Zealand Pharma A/S announced that the FDA has granted priority review designation for dasiglucagon for the prevention and treatment of hypoglycemia in pediatric patients 7 days of age and older with CHI for up to 3 weeks of dosing. The regulatory review will be conducted in two parts under the same NDA.
Part 1 relates to dosing of up to 3 weeks, whereas Part 2 relates to the use beyond 3 weeks.
Supporting the use of dasiglucagon in CHI beyond 3 weeks, the FDA has requested additional analyses from existing continuous glucose monitoring (CGM) datasets, which are expected to be submitted before the end of the year. CGM was included as a secondary outcome measure in one of the two pivotal Phase III clinical trials.
To ensure the most efficient regulatory review process, the FDA has recommended reviewing the NDA submission in two parts. Part 1 of the review relates to dasiglucagon for the prevention and treatment of hypoglycemia in pediatric patients 7 days of age and older with CHI for up to 3 weeks of dosing, whereas Part 2 of the review relates to the same indication but for use beyond 3 weeks of dosing. The FDA has requested additional analyses on the use of CGM from existing datasets supporting the use of dasiglucagon in CHI beyond 3 weeks, which Zealand Pharma expects to submit before the end of the year. Part 2 does not represent a supplemental New Drug Application but is under the same NDA.
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