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UK
31 Mar 2017 15:23 CET

FDA posts briefing materials prior to Advisory Committee meeting for nonacog beta pegol, a long-acting factor IX for the treatment of haemophilia B

Bagsværd, Denmark, 31 March 2017 - Novo Nordisk today announced that the US Food and Drug Administration (FDA) has published the briefing documents ahead of the Advisory Committee meeting to discuss the Biologics License Application for nonacog beta pegol, a long-acting factor IX for the treatment of haemophilia B. The meeting takes place on 4 April 2017.

The briefing documents from Novo Nordisk and the FDA, which will form the basis for the Advisory Committee's discussion, provide an overview of the non-clinical and clinical data for nonacog beta pegol for the treatment of haemophilia B.

The briefing materials can be accessed on the FDA webpage

Further information

Media:    
Katrine Sperling +45 4442 6718 krsp@novonordisk.com
Courtney Mallon (US) +1 609 786 4079 cyml@novonordisk.com
Ken Inchausti (US) +1 609 786 8316 kiau@novonordisk.com
     
Investors:    
Peter Hugreffe Ankersen +45 3075 9085 phak@novonordisk.com
Hanna Ögren +45 3079 8519 haoe@novonordisk.com
Anders Mikkelsen +45 3079 4461 armk@novonordisk.com
Kasper Veje (US) +1 609 235 8567 kpvj@novonordisk.com

Company announcement No 25 / 2017