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Novo Nordisk’s Hemophilia B Drug Faces Safety Scrutiny By US FDA Panel

 
• By Sue Sutter

Novo’s long-acting coagulation Factor IX showed polyethylene glycol (PEG) accumulation in the choroid plexus of animals, potentially raising a neurological safety issue when used in humans, FDA says ahead of Blood Products Advisory Committee review.

A US FDA advisory committee review of Novo Nordisk AS’ investigational hemophilia B treatment nonacog beta pegol will focus on whether a potential safety issue identified in animal studies is likely to translate into neurological adverse events in humans after extended treatment with the long-acting Factor IX replacement.

The Blood Products Advisory Committee will meet April 4 to consider the use of coagulation Factor IX (recombinant), glycoPEGylated – also known as nonacog beta pegol or N9-GP – for the treatment of adults and children with hemophilia B

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