Novo Nordisk receives US FDA approval of REBINYN® (nonacog beta pegol; N9-GP)
(Thomson Reuters ONE) -
Bagsværd, Denmark, 31 May 2017 - Novo Nordisk today announced that the US Food
and Drug Administration (FDA) has approved the Biologics License Application for
REBINYN(®) for the treatment of adults and children with haemophilia B.
REBINYN(®) is the brand name for nonacog beta pegol; N9-GP. REBINYN(®) is
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. The efficacy and safety evaluation was based on
115 patients across the four paradigm clinical trials, and the approval follows
the Blood Products Advisory Committee meeting held 4 April 2017.
"We are excited about the approval of REBINYN(®) in the US, 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. "We are confident that REBINYN(®) will become an
important tool for physicians to help patients manage their bleeds."
Novo Nordisk expects to launch REBINYN(®) in the US in the first half of 2018.
About REBINYN(®)
REBINYN(®) (nonacog beta pegol; N9-GP) is an extended half-life factor IX
molecule for replacement therapy in patients with haemophilia B. The review of
REBINYN(®) 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 REBINYN(®). On 24 March
2017, Novo Nordisk received the positive opinion from the Committee for
Medicinal Products for Human Use (CHMP), under the European Medicines Agency
(EMA), for nonacog beta pegol; N9-GP, 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.
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 40 / 2017
PR170531_Rebinyn_US_approval_UK:
http://hugin.info/2013/R/2109639/801642.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: 31.05.2017 - 20:53 Uhr
Sprache: Deutsch
News-ID 545634
Anzahl Zeichen: 3280
contact information:
Town:
Bagsvaerd
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 149 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Novo Nordisk receives US FDA approval of REBINYN® (nonacog beta pegol; N9-GP)"
steht unter der journalistisch-redaktionellen Verantwortung von
Novo Nordisk A/S (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
