Denmark's Zealand provides US FDA update on drug for low blood sugar in infants
Oct 8 (Reuters) -Denmark's Zealand Pharma ZELA.CO 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
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