Zealand says US FDA turns down drug for low blood sugar in infants

Zealand says US FDA turns down drug for low blood sugar in infants

Dec 23 (Reuters) – Zealand Pharma said on Saturday that the U.S. Food and Drug Administration (FDA) had declined to approve its drug for preventing and treating low blood sugar in children with a genetic disorder after finding deficiencies at a third-party manufacturing facility.

Zealand (ZELA.CO) 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.

The Danish drugmaker said that the FDA did not state any immediate concerns about the clinical data package or safety of the drug, but had raised concerns about “deficiencies” it found at the third-party manufacturing facility after an inspection.

“These deficiencies are not specific to dasiglucagon,” Zealand said in a statement, adding that it would work with the FDA and the third-party manufacturer to resolve the issues.

“Zealand expects to resubmit the NDA (new drug application) for dasiglucagon for CHI for up to three weeks of dosing in the first half of 2024 contingent on successful reinspection of the third-party manufacturing facility,” it said in a statement.

Zealand said the FDA, which did not immediately reply to a Reuters request for comment, 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.

It also said that the agency requested more data in regards to dosing of the drug beyond the three weeks period, which the company expects to provide by the middle of next year.

“Based on our understanding of the FDA’s position, we remain confident in the potential for dasiglucagon to help children and their families affected by congenital hyperinsulinism,” said David Kendall, Zealand’s Chief Medical Officer.

Our Standards: The Thomson Reuters Trust Principles.

Source: Reuters