Zealand Pharma: FDA Issues CRL For Dasiglucagon In Congenital Hyperinsulinism

(RTTNews) - Zealand Pharma A/S (ZEAL) said that the U.S. Food and Drug Administration has issued a Complete Response Letter or CRL for Part 1 of the New Drug Application or NDA for dasiglucagon for the prevention and treatment of hypoglycemia in pediatric patients 7 days of age and older with congenital hyperinsulinism or CHI for up to 3 weeks of dosing.

According to the company, the CRL is related to the timing of a reinspection at a third-party contract manufacturing facility that was completed in August/September 2024. The third-party manufacturer has not yet received its inspection classification following the reinspection. A prior inspection of the facility had identified deficiencies that did not involve dasiglucagon. These prior deficiencies had been resolved as of this reinspection.

The company noted that the CRL did not state any concerns about the clinical data package or safety of dasiglucagon.

The regulatory review of dasiglucagon is being 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. The FDA requested additional analyses from existing continuous glucose monitoring (CGM) datasets from the Phase 3 clinical program. Zealand expects to submit these data by the end of 2024.

Congenital hyperinsulinism is a severe, ultra-rare genetic disease, primarily affecting infants and children, in which the pancreatic beta cells dysfunction and secrete too much insulin, leading to frequent, recurrent, and often severe episodes of hypoglycemia. Persistent episodes of hypoglycemia can result in seizure, brain damage and death.

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