US FDA extends review of Novo Nordisk’s hemophilia drug over facility issues

Oct 2 (Reuters) – The US FDA has extended its review of Novo Nordisk’s experimental hemophilia A drug due to ongoing remediation work at a manufacturing facility, the Danish drugmaker said on Friday.

Here are some details:

• The company was seeking the US Food and Drug Administration’s approval for denecimig to treat adults and children with hemophilia A, with or without inhibitors, a rare condition that prevents the blood from clotting properly.

• Novo had submitted the application for denecimig in September 2025 and was expecting an FDA decision in the third quarter of 2026.

• While the regulator has not yet set a new timeline for its decision, Novo said the FDA did not raise any concerns regarding the safety or effectiveness data from the drug’s clinical trials.

• The company said the manufacturing site issues do not impact any of its other medicines currently on the market.

• “Novo is already in the process of addressing the FDA’s requests as efficiently as possible and continuing to work closely with the agency,” CEO Mike Doustdar said in a statement.

• The company said it still aims to launch denecimig in the US in the first half of 2027, subject to regulatory approval.

• The delay would not affect its 2026 financial forecast, Novo said.

(Reporting by Kamal Choudhury in Bengaluru; Editing by Shilpi Majumdar)

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