The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to Zealand Pharma, declining the approval of dasiglucagon for the treatment and prevention of hypoglycaemia in infants with congenital hyperinsulinism (CHI).

The CRL, which pertains to Part 1 of the new drug application (NDA) for patients aged seven days and older, cites the need for a reinspection at a third-party manufacturing facility.

This regulatory decision is linked to the timing of a reinspection at a contract manufacturing site that concluded in August/September 2024.

The facility, responsible for producing dasiglucagon, has not received its inspection classification post-reinspection.

Although a previous inspection had identified deficiencies, they were not related to dasiglucagon and had been addressed by the time of the latest reinspection.

The CRL did not raise any concerns regarding the clinical data or the safety profile of dasiglucagon.

Zealand Pharma’s NDA for dasiglucagon is currently undergoing a two-part regulatory review.

While Part 1 involved dosing for up to three weeks, Part 2 will cover usage beyond that period.

The FDA has requested additional analyses from existing continuous glucose monitoring data collected during Phase III clinical trials to support the use of dasiglucagon in CHI for extended periods.

Zealand Pharma anticipates submitting the required data by the end of 2024.

Zealand Pharma chief medical officer David Kendall said: “We at Zealand Pharma are acutely aware of the significant unmet medical need for newborns and children with congenital hyperinsulinism who have either no or very limited treatment options today.

“We are committed to working with the FDA and our third-party manufacturing partner to bring dasiglucagon to patients living with this devastating disease in the months ahead.”