US FDA Extends Review of Novo Nordisk's Hemophilia Drug Amid Manufacturing Remediation
Bengaluru: 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.
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.
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