Oct 8 (Reuters) - The U.S. health regulator has declined

to approve Zealand Pharma's drug to prevent and treat

low blood sugar in children with a genetic disorder, the Danish

biotech firm said on Tuesday, marking the second rejection for

the treatment.

The Food and Drug Administration (FDA) in its so-called

"complete response letter" cited the timing of a third-party

manufacturing facility reinspection for the decision, the

company said. The letter, however, did not mention any concerns

about the clinical data package or safety of the drug,

dasiglucagon.

Dasiglucagon was previously declined after an initial turn

down by the FDA citing deficiencies at a third-party

manufacturing facility. It is meant for use in patients aged

seven days or older with congenital hyperinsulinism (CHI), a

rare genetic disorder which affects about 1 in 50,000 newborns.

CHI causes abnormally high levels of insulin, a hormone that

controls blood glucose levels, and leads to frequent episodes of

low blood sugar or hypoglycemia.

The drugmaker said it would work with the regulator and the

third-party manufacturer to bring dasiglucagon to patients in

the U.S. as soon as possible.

Zealand said the FDA plans to make two separate approval

decisions - one for use of the drug for up to three weeks of

dosing, and a second for dosing beyond that time period.

The regulator has requested additional data for the drug in

its use beyond 3 weeks, Zealand said in a statement adding that

it expects to submit data by the end of 2024.

The FDA did not immediately reply to a Reuters request for

comment.