CHMP endorses Tresiba® label update in the EU - new label reflects significant reduction in the risk of severe hypoglycaemia
(Thomson Reuters ONE) -
Bagsværd, Denmark, 29 September 2017 - Novo Nordisk today announced that the
Committee for Medicinal Products for Human Use (CHMP), under the European
Medicines Agency (EMA), has endorsed an update of the EU label with immediate
effect for Tresiba(® )(insulin degludec) to include results from the DEVOTE
trial on severe hypoglycaemia. DEVOTE is a randomised, multinational and double-
blinded 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 trial, the primary endpoint was achieved by demonstrating non-inferiority
of major adverse cardiovascular events (MACE) with Tresiba(®) compared to
insulin glargine U100. Severe hypoglycaemia was evaluated as a secondary
endpoint and 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 53% relative reduction in the rate of
nocturnal severe hypoglycaemia. These differences were all statistically
significant.
"Our ambition is to help people with type 2 diabetes reach their treatment goals
and at the same time reduce their risk of severe hypoglycaemia," said Mads
Krogsgaard Thomsen, executive vice president and chief science officer of Novo
Nordisk. "With the CHMP's endorsement of the updated label for Tresiba(®) we
have passed a major milestone in insulin therapy."
About the DEVOTE trial
DEVOTE is the first cardiovascular outcomes trial (CVOT) comparing two basal
insulins. DEVOTE is a multinational, double-blinded clinical trial which
investigated the cardiovascular safety of Tresiba(®) compared with insulin
glargine U100 over 104 weeks. In the trial, 7,637 people with type 2 diabetes at
high risk of, or existing, cardiovascular disease were randomised to treatment
with either Tresiba(®) or insulin glargine U100 in vial in addition to standard
of care.
In the trial, the primary endpoint was achieved by demonstrating non-inferiority
of MACE with Tresiba(®) compared to insulin glargine U100. The primary endpoint
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.
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(®) was approved by the European Commission in
January 2013 and has since been approved in more than 80 countries globally.
Novo Nordisk is a global healthcare company with more than 90 years of
innovation and leadership in diabetes care. This heritage has given us
experience and capabilities that also enable us to help people defeat other
serious chronic conditions: haemophilia, growth disorders and obesity.
Headquartered in Denmark, Novo Nordisk employs approximately 41,400 people in
77 countries and markets its products in more than 165 countries. Novo Nordisk's
B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the
New York Stock Exchange (NVO). For more information, visit novonordisk.com,
Facebook, Twitter, LinkedIn, YouTube
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
Christina Kjær +45 3079 3009 cnje(at)novonordisk.com
Kasper Veje (US) +1 609 235 8567 kpvj(at)novonordisk.com
Company Announcement No 73/2017
Company Announcement No 73 / 2017:
http://hugin.info/2013/R/2138108/818468.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: 29.09.2017 - 15:52 Uhr
Sprache: Deutsch
News-ID 561925
Anzahl Zeichen: 5204
contact information:
Town:
Bagsvaerd
Kategorie:
Business News
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