Novo Nordisk submits application in the US for including data from the DEVOTE trial in the Tresiba® label
(Thomson Reuters ONE) -
Bagsværd, Denmark, 27 May 2017 - Novo Nordisk today announced the submission of
a supplemental application to the US Food and Drug Administration (FDA) for
including data in the label for Tresiba(® )(insulin degludec) from the DEVOTE
trial, a long-term, randomised, double-blinded and event-driven trial conducted
to confirm the cardiovascular safety of Tresiba(®) compared to insulin glargine
U100 when added to standard of care, in people with type 2 diabetes.
In the DEVOTE trial, the primary endpoint was achieved by demonstrating non-
inferiority of major adverse cardiovascular events (MACE) with Tresiba(®)
compared to insulin glargine U100. The trial thereby confirmed the results of
the DEVOTE interim analysis submitted to the FDA in March 2015, on the basis of
which Tresiba(®) and Ryzodeg(®) 70/30 were approved in the US in September 2015.
The primary endpoint of the DEVOTE study was defined as the MACE composite
outcome of the first occurrence of cardiovascular death, non-fatal myocardial
infarction or non-fatal stroke and showed a hazard ratio of 0.91 in favour of
Tresiba(®) relative to insulin glargine U100, with no statistically significant
difference between the two treatments.
From a mean HbA(1c) baseline of 8.4%, the trial showed a similar reduction with
Tresiba(®) compared to insulin glargine U100 with an end-of-trial treatment
difference of 0.01 percentage points between the two treatment arms, thus
fulfilling the requirements for objectively comparing hypoglycaemia rates
between the two treatments.
In the trial, Tresiba(®) demonstrated superiority on the secondary confirmatory
endpoint of severe hypoglycaemia: 27% fewer patients in the Tresiba(®) treated
group experienced an episode of severe hypoglycaemia, resulting in a 40% overall
rate reduction of total episodes of adjudicated severe hypoglycaemia.
Furthermore, patients in the Tresiba(®) treated group experienced a 54% relative
reduction in the rate of nocturnal severe hypoglycaemia. These differences were
all statistically significant.
Tresiba(®) appeared to have a safe and well-tolerated profile consistent with
previous clinical studies conducted with Tresiba(®).
"The risk of severe hypoglycaemia is a major cause for people with type 2
diabetes not reaching their treatment targets," said Mads Krogsgaard Thomsen,
executive vice president and chief science officer of Novo Nordisk. "However,
with the DEVOTE data, we have demonstrated that the strong clinical profile of
Tresiba(®) leads to a significant reduction in severe hypoglycaemia in people
with type 2 diabetes."
About DEVOTE
DEVOTE is a long-term, multi-centre, multi-national, randomised, double-blinded,
parallel group and event-driven trial conducted to confirm the cardiovascular
safety of Tresiba(®) (insulin degludec) compared to insulin glargine U100. In
the trial, 7,637 people with type 2 diabetes at high risk of cardiovascular
disease were randomised to treatment with either Tresiba(®) or insulin glargine
U100 in vial in addition to standard of care.
The DEVOTE trial has been conducted in response to a Complete Response Letter
received from the FDA in February 2013 requesting additional cardiovascular data
from a dedicated cardiovascular outcomes trial before the review of the New Drug
Applications for Tresiba(®) and Ryzodeg(®) 70/30 could be concluded. Tresiba(®)
and Ryzodeg(®) 70/30 were approved in the US in September 2015 on the basis of
an interim analysis of DEVOTE.
About Tresiba(®)
Tresiba(®) (insulin degludec) is a once-daily basal insulin that provides
duration of action of at least 42 hours. Tresiba(®) is taken once daily, at any
time of day. Patients who miss or are delayed in taking their dose of Tresiba(®)
can take their dose as soon as they remember, but ensuring there are at least
eight hours between doses. Tresiba(®) received its first regulatory approval in
September 2012 and has since been approved in more than 80 countries globally.
It was approved by the US FDA in September 2015.
Further information
Media:
Katrine Sperling +45 4442 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 39 / 2017
PR170527_Tresiba_DEVOTE_US filing_UK:
http://hugin.info/2013/R/2108017/800620.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: 27.05.2017 - 16:18 Uhr
Sprache: Deutsch
News-ID 544862
Anzahl Zeichen: 5530
contact information:
Town:
Bagsvaerd
Kategorie:
Business News
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