Drugs

Zealand Hypoglycemia NDA Denied FDA Approval

FDA has issued Zealand Pharma a complete response letter (CRL) on its NDA for dasiglucagon and its use in preventing and treating hypoglycemia in pediatric patients seven days of age and older with congenital hyperinsulinism (CHI) for up to three weeks of dosing.

“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 company says. The manufacturer has not yet received an inspection classification after the reinspection. “A prior inspection of the facility had identified deficiencies that did not involve dasiglucagon,” it says, adding that the prior deficiencies had been resolved before the reinspection. Zealand also notes 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 three weeks and Part 2 relates to the use beyond three weeks,” Zealand says. “Supporting the use of dasiglucagon in CHI beyond three 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.”

Dasiglucagon is described as a glucagon receptor agonist that works by causing the liver to release stored sugar to the blood. It was designed to be administered by continuous subcutaneous infusion using a wearable pump system, according to the company.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome