NOVO NORDISK A/S 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: https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/BloodProductsAdvisoryCommittee/ucm543914.htm
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
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Novo Nordisk A/S via Globenewswire
