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Novo Hemophilia Drug's Postmarket Monitoring Plan Not Robust Enough – US Panel

 
• By Sue Sutter

FDA advisory committee members support approval of investigational hemophilia B treatment nonacog beta pegol but say Novo Nordisk needs more systematic approach to monitoring for neurological and developmental adverse events.

Novo Nordisk AS’ investigational hemophilia B treatment nonacog beta pegol appears headed for US FDA approval but likely will require more robust and systematic postmarket safety monitoring than proposed by the company at an April 4 advisory committee meeting.

Although there was no vote on approval, members of FDA’s Blood Products Advisory Committee supported use of coagulation Factor IX (recombinant), glycoPEGylated (also known as nonacog beta pegol or N9-GP) in adults and children with hemophilia B for control

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