The FDA handed down a second complete response letter to Zealand Pharma for its glucagon receptor agonist in an ultra-rare genetic disease called congenital hyperinsulinism for pediatric patients.
According to Zealand, the CRL for dasiglucagon has to do with a reinspection of a third-party manufacturing facility. The company said the reinspection was completed in August or September, though the facility hasn’t received its inspection classification yet. It noted that the rejection has nothing to do with the safety or clinical data of the drug.
“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,” Zealand CMO David Kendall said in a statement.
The FDA rejected the drug for the first time last December, due to “deficiencies identified following an inspection at a third-party contract manufacturing facility.”
Dasiglucagon’s application has two parts: The first is for dosing up to three weeks, and the second is for dosing beyond three weeks. The CRL impacts the first part of the application. The second part of the application is currently underway after the FDA asked Zealand to submit more analyses from existing continuous glucose monitoring datasets from the Phase 3 trial. Zealand said it expects to submit the additional data by the end of this year.
The drug won FDA approval as Zegalogue in 2021 for severe hypoglycemia in adults and children with diabetes. Zegalogue is licensed to Novo Nordisk, which is responsible for global commercialization.