Refixia® (nonacog beta pegol; N9-GP) approved
(Thomson Reuters ONE) -
Bagsværd, Denmark, 6 June 2017 - Novo Nordisk today announced that the European
Commission has granted marketing authorisation for Refixia(®) for the treatment
of adolescents and adults with haemophilia B. The authorisation covers all 28
European Union member states.
Refixia(®) is the brand name for nonacog beta pegol; N9-GP. Refixia(®) is
indicated for prophylaxis, on-demand treatment of bleeding and surgical
procedures in adolescent (>12 years of age) and adult patients with haemophilia
B (congenital factor IX deficiency). The efficacy and safety evaluation was
based on 115 patients across the five paradigm clinical trials, and the
marketing authorisation follows the positive opinion from the Committee for
Medicinal Products for Human Use (CHMP), under the European Medicines Agency
(EMA), provided 24 March 2017.
"We are excited about the approval of Refixia(®) in the EU, and we consider it
an important expansion of the treatment options for patients with haemophilia
B," said Mads Krogsgaard Thomsen, executive vice president and chief science
officer of Novo Nordisk. "The strong clinical profile of Refixia(®) provides
haemophilia B patients with better protection against bleeds, even into damaged
joints, and an overall improved quality of life."
Novo Nordisk expects to launch Refixia(®) in the first European countries in the
fourth quarter of 2017.
About Refixia(®)
Refixia(®) (nonacog beta pegol; N9-GP) is an extended half-life factor IX
molecule for replacement therapy in patients with haemophilia B.
Glycopegylation, the prolongation technology used for the half-life extension,
is a novel approach in haemophilia B. Pegylated products have been approved in
haemophilia A and other therapeutic areas. The review of Refixia(®) was based on
the paradigm programme, a phase 3 clinical programme enrolling children and
adults with severe or moderately severe haemophilia B. In the programme, 115
previously treated patients had a total of more than 8,800 exposure days for up
to 2.7 years of treatment with Refixia(®). On 31 May 2017, Novo Nordisk received
the US FDA approval of nonacog beta pegol; N9-GP indicated for on-demand
treatment and control of bleeding episodes and the perioperative management of
bleeding around the time of surgery in adults and children with haemophilia B.
Novo Nordisk is a global healthcare company with more than 90 years of
innovation and leadership in diabetes care. This heritage has given us
experience and capabilities that also enable us to help people defeat other
serious chronic conditions: haemophilia, growth disorders and obesity.
Headquartered in Denmark, Novo Nordisk employs approximately 42,000 people in
77 countries and markets its products in more than 165 countries. Novo Nordisk's
B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the
New York Stock Exchange (NVO). For more information, visit novonordisk.com,
Facebook, Twitter, LinkedIn, YouTube
Further information
Media:
Katrine Sperling +45 3079 6718 krsp(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 42/2017
Company Announcement No 42/2017:
http://hugin.info/2013/R/2110891/802389.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: 06.06.2017 - 16:56 Uhr
Sprache: Deutsch
News-ID 546588
Anzahl Zeichen: 4394
contact information:
Town:
Bagsvaerd
Kategorie:
Business News
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