The US Food and Drug Administration (FDA) has granted priority review for Zealand Pharma’s dasiglucagon for hypoglycemia prevention and treatment in the paediatric population with congenital hyperinsulinism (CHI), a rare genetic ailment.
Dasiglucagon is intended for usage in infants aged seven days and above, dosing for up to three weeks.
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A decision on the approval from the regulatory agency is anticipated on 30 December 2023.
The regulator will carry out the review in two stages under one new drug application (NDA) to guarantee the best regulatory approach.
Part one is linked to dosing with dasiglucagon for up to three weeks while part two is linked to the product’s usage beyond that time.
To assess the usage of dasiglucagon for the disease beyond three weeks, the regulator sought further assessments from existing continuous glucose monitoring datasets.
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By GlobalDataZealand Pharma is expected to make the submission before the end of 2023.
The Prescription Drug User Fee Act (PDUFA) date for the second part will be decided after filing data from further analyses of existing datasets sought by the FDA.
The company chose CGM as a secondary outcome measure in Phase III clinical trials of dasiglucagon.
Zealand Pharma chief medical officer David Kendall stated: “We believe that the decision of the FDA to provide such a fast review cycle for the first part of the NDA is a strong testament to the potential value of this product to patients.
“We remain in close dialogue with the FDA and appreciate the collaborative nature of our work with the agency, recommending a review of the NDA in two parts under the same application to ensure patient access as fast as possible.
“We look forward to continued dialogue with the FDA in generating additional analyses from existing datasets around the use of CGM to be submitted before the end of the year for part two of the NDA review.”
