FDA rejects Zealand’s hypoglycemia filing over CDMO's manufacturing problems

Danish biotech Zealand Pharma has been issued an FDA complete response letter for its pediatric hypoglycemia drug after manufacturing problems were uncovered at the facility of third-party CDMO.

The FDA's rejection centers on the company’s application for dasiglucagon for the prevention and treatment of hypoglycemia in pediatric patients who are 7 days of age and older with congenital hyperinsulinism (CHI) for up to 3 weeks of dosing, the company said in a December 24 press release.

The manufacturing problems were not specific to the treatment itself and the letter from the regulatory agency didn’t state any problems or concerns about the clinical data package or safety of the drug, Zealand said. The identity of the CDMO and the specific manufacturing issues weren’t disclosed.

“We are committed to working closely with the FDA and the third-party manufacturer to resolve these issues so that we can bring dasiglucagon to patients living with this devastating disease who are in need of new treatment options,” David Kendall, Zealand’ chief medical officer, said in the release. “Based on our understanding of the FDA’s position, we remain confident in the potential for dasiglucagon to help children and their families affected by congenital hyperinsulinism.”

The company will likely resubmit the application in the first half of 2024 contingent on a successful re-inspection of the third-party manufacturing facility.

Zealand's drug won FDA approval in March 2022 to treat severe low blood sugar in diabetes. Several months later, the company inked a global license and development pact with Novo Nordisk to allow the Danish pharma juggernaut take the marketing reins on Zegalogue (dasiglucagon), which was Zealand’s first launch.