Novo Nordisk receives US FDA approval for Tresiba® and Ryzodeg® 70/30
(Thomson Reuters ONE) -
Bagsværd, Denmark, 25 September 2015 - Novo Nordisk today announced that the US
Food and Drug Administration (FDA) has approved Tresiba(®) and Ryzodeg(®) 70/30
for the treatment of diabetes mellitus in adults after review of the class II
resubmissions of the New Drug Applications (NDAs).
Tresiba(®), the approved brand name for insulin degludec, is a once-daily new-
generation basal insulin analogue with a half-life of 25 hours and a duration of
action of at least 42 hours. In 'treat-to-target' studies comparing Tresiba(®)
to insulin glargine, people using Tresiba(®) achieved similar reduction in long-
term blood glucose (HbA(1c)), numerically greater fasting plasma glucose
reduction, while using numerically lower doses of insulin in a majority of the
studies. Furthermore, the studies demonstrated that Tresiba(®) is the first
basal insulin to offer people with diabetes the possibility of injecting their
basal insulin at any time of the day with the option to adjust the time of
injection.
Ryzodeg(®) 70/30, the approved brand name for insulin degludec/insulin aspart,
contains insulin degludec in a soluble co-formulation with insulin aspart.
Ryzodeg(®) 70/30 can be administered once or twice daily with any main meal. In
a 'treat-to-target' study supporting the new drug application where Ryzodeg(®)
70/30 was compared to NovoLog(® )Mix 70/30, Ryzodeg(®) 70/30 showed equivalent
reductions in HbA(1c).
Novo Nordisk expects to launch Tresiba(®) in the US during the first quarter of
2016. Tresiba(®) will be available in the FlexTouch(®) device and be offered in
two concentrations enabling maximum doses of 80 units and 160 units per
injection, respectively.
On 26 March 2015, Novo Nordisk announced the decision to submit the class II
resubmissions of the NDAs following the completion of the interim analysis of
the cardiovascular outcomes trial for insulin degludec, DEVOTE. In order to
preserve the integrity of the ongoing DEVOTE trial, only a small dedicated team
within Novo Nordisk has access to the data. Novo Nordisk management does not
have access to the results of the interim analysis. The trial is still expected
to have accrued the prespecified number of major adverse cardiovascular events
(MACE) for the full trial analysis in mid-2016.
"We are very happy with FDA's decision to approve Tresiba(®) and Ryzodeg(®)
70/30 as we believe these products offer significant benefits and important
treatment options for people with type 1 and type 2 diabetes", said Lars Rebien
Sørensen, president and chief executive officer of Novo Nordisk. "The approvals
mark an important milestone for Novo Nordisk and we look forward to making
Tresiba(®) available for people in the US".
Reflecting a separate action, Novo Nordisk today also announced that a New Drug
Application for Xultophy(®), the first once-daily single-injection combination
of Tresiba(®) (insulin degludec) and Victoza(®) (liraglutide), has been
submitted to the FDA. The submission is expected to be reviewed under US FDA's
Prescription Drug User Fee Act V (PDUFA V).
Conference call
On 28 September 2015 at 8.00 am CEST, corresponding to 2.00 am EDT, a conference
call for investors will be held. Investors will be able to listen in via a link
on the investor section of novonordisk.com.
Further information
Media:
Mike Rulis +45 3079 3573 mike(at)novonordisk.com
Ken Inchausti (US) +1 609 514 8316 kiau(at)novonordisk.com
Investors:
Peter Hugreffe Ankersen +45 3075 9085 phak(at)novonordisk.com
Daniel Bohsen +45 3079 6376 dabo(at)novonordisk.com
Melanie Raouzeos +45 3075 3479 mrz(at)novonordisk.com
Kasper Veje +45 3079 8519 kpvj(at)novonordisk.com
Frank Daniel Mersebach (US) +1 609 235 8567 fdni(at)novonordisk.com
Company announcement No 58 / 2015
Company announcement No 58 / 2015:
http://hugin.info/2013/R/1954709/711421.pdf
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Novo Nordisk A/S via GlobeNewswire
[HUG#1954709]
Unternehmensinformation / Kurzprofil:
Datum: 25.09.2015 - 20:53 Uhr
Sprache: Deutsch
News-ID 422785
Anzahl Zeichen: 4989
contact information:
Town:
Bagsvaerd
Kategorie:
Business News
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