Bli medlem
Bli medlem

Du är här


Novo Nordisk A/S: Novo Nordisk receives US FDA approval for Tresiba® and Ryzodeg® 70/30

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 (HbA1c), 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 HbA1c.

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 theinvestor section of

Further information

| Media: |
| Mike Rulis +45 3079 3573 |
| Ken Inchausti (US) +1 609 514 8316 |
| Investors: |
| Peter Hugreffe Ankersen +45 3075 9085 |
| Daniel Bohsen +45 3079 6376 |
| Melanie Raouzeos +45 3075 3479 |
| Kasper Veje +45 3079 8519 |
| Frank Daniel Mersebach (US) +1 609 235 8567 |
Company announcement No 58 / 2015

Company announcement No 58 / 2015


This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX 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


Författare Hugin

Tala om vad ni tycker

Tala om vad ni tycker

Ni är just nu inne på en betaversion av nya aktiespararna. Lämna gärna feedback på vad ni tycker i formuläret nedan.