Danish biotech, Zealand Pharma, has faced its second FDA rejection for its hypoglycemia drug - dasiglucagon - which is tied to manufacturing issues uncovered during a CDMO inspection. Despite the setback, Zealand said it remains committed to resolving the issues and pursuing approval for the drug, which is designed to treat severe low blood sugar in diabetic patients.

The following article originally appeared in Fierce Pharma.

After third-party manufacturing issues led to a December rejection of Zealand Pharma’s pediatric congenital hyperinsulinism (CHI) candidate, the Danish pharma’s latest snub seems to come down to timing and bad luck.

Zealand’s glucagon receptor agonist dasiglucagon has been rebuffed by the FDA once again, scrambling the company's plan to launch the hypoglycemia drug in kids with CHI who are 7 days of age and older for up to 3 weeks of dosing.

CHI is a severe, ultra-rare genetic disease that primarily affects infants and kids. In patients with the disease, pancreatic beta cells don’t work properly and secrete too much insulin, leading to frequent, recurrent and often severe episodes of low blood sugar that can cause seizures, brain damage and even death, Zealand explained in a release Wednesday.

Zealand blamed the FDA complete response letter (CRL) on the timing of a reinspection of a third-party production plant that was completed in August and September.

The problem is that the manufacturer—which isn’t named in the release—has yet to receive an inspection classification, putting Zealand’s approval hopes on hold.

A prior inspection of the plant revealed deficiencies unrelated to dasiglucagon, but those manufacturing shortfalls had been resolved by the time of the reinspection, Zealand stressed.

The latest rejection made no mention about concerns tied to dasiglucagon’s clinical data or safety.

“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,” David Kendall, M.D., Zealand’s chief medical officer, said in a statement.

The CRL specifically covers Part 1 of Zealand’s application for dasiglucagon, which relates to dosing of up to three weeks. The second part of the application is tied to dosing after three weeks, Zealand explained.

For the application’s second half, the FDA has requested additional analyses from existing continuous glucose monitoring datasets generated as part of dasiglucagon’s phase 3 program. Zealand says it plans to submit those data by the end of the year.

Dasiglucagon was first turned away by the FDA in December thanks to problems uncovered during the agency's inspection of a third-party manufacturing plant. At the time, Zealand said it would likely resubmit its application in the first half of 2024, contingent upon the successful reinspection of the facility.

Dasiglucagon is already approved to treat severe low blood sugar in diabetes.

After winning an approval for dasiglucagon under the brand name Zegalogue in 2021, Zealand in late 2022 tapped Novo Nordisk to take over marketing on the launch after initial sales failed to impress.

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