FDA issues CRL for dasiglucagon in congenital hyperinsulinism
Shares of Denmark-based Zealand Pharma (Nasdaq: ZEAL) dipped 4.9% to 355.00 kroner by late afternoon, on negative news from the US medicines regulator.
The company revealed that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for Part 1 of the New Drug Application (NDA) for dasiglucagon for the prevention and treatment of 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 deficiencies identified following an inspection at a third-party contract manufacturing facility. These deficiencies are not specific to dasiglucagon. The CRL did not state any concerns about the clinical data package or safety of dasiglucagon.
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