US regulators said Novo Nordisk A/S failed to properly investigate bacterial contamination earlier this year at a plant that makes one of its best-selling diabetes drugs.
(Bloomberg) — US regulators said Novo Nordisk A/S failed to properly investigate bacterial contamination earlier this year at a plant that makes one of its best-selling diabetes drugs.
Bacteria showed up in batches of semaglutide, the active ingredient in the diabetes medicine Rybelsus, on at least three occasions between February and June when inspectors visited the plant in Clayton, North Carolina, according to a US Food and Drug Administration report obtained through a Freedom of Information Act request.
The report, issued in July, said the source of the contamination had yet to be determined and corrective actions taken by the company were inadequate. The plant in Clayton manufactures semaglutide specifically for Rybelsus, an oral diabetes medication, but not for Ozempic or Wegovy, a spokesperson said.
After the company’s corrective actions, the FDA said in an email Thursday that it “does not have information that suggests ongoing compliance issues that raise concerns about the quality of drug products manufactured at the site.”
Novo shares fell as much as 1.3% in Copenhagen trading. They also dropped on Monday amid market speculation that the Danish drugmaker had received the so-called Form 483 from the FDA, which notifies company management of any objectionable conditions found during routine inspections. The stock has climbed about 40% this year.
The site in question was “running and producing for the market,” Novo said in response to Bloomberg’s questions about the FDA notice earlier this week.
The company has been struggling to keep up with fervent demand for its medicines Ozempic and Wegovy. Analysts from Jefferies said the FDA notice isn’t likely to have a material impact on semaglutide supply going forward.
“Stepping back, we’ve seen other Form 483s/warning letters raising concerns, including bacterial contamination. That said, they rarely prevented ongoing supply,” the Jefferies note said.
–With assistance from Anna Edney and Naomi Kresge.
(Updates with FDA comments on current situation in fourth paragraph, Novo shares in fifth)
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