(Reuters) – Denmark’s Zealand Pharma said on Tuesday the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) relating to its drug for preventing and treating low blood sugar in children with a genetic disorder.
Zealand is seeking FDA approval for dasiglucagon, which it plans to use in patients aged seven days or older with congenital hyperinsulinism (CHI), a genetic disorder in which the pancreas secretes too much insulin.
(Reporting by Gursimran Kaur in Bengaluru; Editing by Shreya Biswas)
