Novo Nordisk receives positive opinion from the European regulatory authorities for Refixia® (nonacog beta pegol, N9-GP) for the treatment of haemophilia B
(Thomson Reuters ONE) -
Bagsværd, Denmark, 24 March 2017 - Novo Nordisk today announced that the
Committee for Medicinal Products for Human Use (CHMP), under the European
Medicines Agency (EMA), adopted a positive opinion for the use of Refixia(®)
(nonacog beta pegol, N9-GP), recommending marketing authorisation for the
treatment of adolescents and adults with haemophilia B.
The CHMP recommends Refixia(®), the brand name for nonacog beta pegol, N9-GP, to
be indicated for prophylaxis and on-demand treatment of bleeding as well as for
surgical procedures in adolescent (>12 years of age) and adult patients with
haemophilia B (congenital factor IX deficiency). The recommendation is based on
the results from the paradigm clinical trial programme, where 115 previously
treated children and adults with haemophilia B were treated with Refixia(®).
"We are excited about the positive opinion obtained for Refixia(®) and it
represents a significant milestone in our efforts to expand the treatment
options for patients with haemophilia," said Mads Krogsgaard Thomsen, executive
vice president and chief scientific officer of Novo Nordisk. "We believe
Refixia(®) with its strong clinical profile provides haemophilia B patients
better protection against bleeds, even into damaged joints, and an overall
improved quality of life."
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(®).
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 22 / 2017
PR170324_N9GP_CHMP_UK:
http://hugin.info/2013/R/2090457/789402.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: 24.03.2017 - 13:22 Uhr
Sprache: Deutsch
News-ID 532310
Anzahl Zeichen: 3277
contact information:
Town:
Bagsvaerd
Kategorie:
Business News
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