US FDA declines to approve Zealand’s drug for low blood sugar in infants

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(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.

(Reporting by Gursimran Kaur and Mariam Sunny in Bengaluru; Editing by Shreya Biswas and Shailesh Kuber)

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