FDA posts briefing materials prior to Advisory Committee meeting for nonacog beta pegol, a long-acting factor IX for the treatment of haemophilia B
(Thomson Reuters ONE) -
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/Blood
VaccinesandOtherBiologics/BloodProductsAdvisoryCommittee/ucm543914.htm
Further information
Media:
Katrine Sperling +45 4442 6718 krsp(at)novonordisk.com
Courtney Mallon (US) +1 609 786 4079 cyml(at)novonordisk.com
Ken Inchausti (US) +1 609 786 8316 kiau(at)novonordisk.com
Investors:
Peter Hugreffe Ankersen +45 3075 9085 phak(at)novonordisk.com
Hanna Ögren +45 3079 8519 haoe(at)novonordisk.com
Anders Mikkelsen +45 3079 4461 armk(at)novonordisk.com
Kasper Veje (US) +1 609 235 8567 kpvj(at)novonordisk.com
Company announcement No 25 / 2017
Company Announcement No 25/2017:
http://hugin.info/2013/R/2092699/790897.pdf
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
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
Unternehmensinformation / Kurzprofil:
Datum: 31.03.2017 - 15:24 Uhr
Sprache: Deutsch
News-ID 533752
Anzahl Zeichen: 2072
contact information:
Town:
Bagsvaerd
Kategorie:
Business News
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