Novo Nordisk A/S: CHMP endorses EU label update of Saxenda® based on the LEADER trial
(Thomson Reuters ONE) -
Bagsværd, Denmark, 22 June 2017 - Novo Nordisk today announced that the
Committee for Medicinal Products for Human Use (CHMP), under theEuropean
Medicines Agency (EMA), has endorsed an update of the EU label for Saxenda(®).
This update is based on the results from the LEADER trial which investigated the
long-term effects of Victoza(®) in people with type 2 diabetes and established
cardiovascular disease.
The CHMP has previously concluded that, although the Saxenda(®) dosing of
liraglutide 3.0 mg was not investigated in the LEADER trial, the results would
also be supportive for the assessment of Saxenda(®) for any potential
cardiovascular risk. The Saxenda(®) label has been updated with immediate effect
to reflect the primary outcome of the LEADER trial.
In the LEADER trial, Victoza(®) (liraglutide 1.8 mg) statistically significantly
reduced the risk of cardiovascular death, non-fatal myocardial infarction (heart
attack) and non-fatal stroke by 13% versus placebo, when added to standard of
care. The overall risk reduction was derived from a statistically significant
22% reduction in cardiovascular death with Victoza(®) treatment versus placebo
and non-significant reductions in non-fatal myocardial infarction and non-fatal
stroke.
"We are very pleased that data from the LEADER trial has been included in the
Saxenda(®) label in Europe," said Mads Krogsgaard Thomsen, executive vice
president and chief scientific officer of Novo Nordisk. "The LEADER trial showed
that liraglutide is associated with significant cardiovascular risk reduction in
people type 2 diabetes. This is an important development for people with obesity
in Europe living with weight-related comorbidities such as cardiovascular
disease."
On 25 October 2016, Novo Nordisk submitted an application to the EMA for
including data from the LEADER cardiovascular outcomes trial in the product
information of Victoza(®). Novo Nordisk expects feedback from the EMA on the
Victoza(®) application shortly.
About Saxenda(®)
Saxenda(®) (liraglutide 3 mg) is a once-daily glucagon-like peptide-1 (GLP-1)
analogue with 97% similarity to naturally occurring human GLP-1, a hormone that
is released in response to food intake. Like human GLP-1, Saxenda(®) regulates
appetite by increasing feelings of fullness and satiety, while lowering feelings
of hunger and prospective food consumption, thereby leading to reduced food
intake. As with other GLP-1 receptor agonists, Saxenda(®) stimulates insulin
secretion and lowers glucagon secretion in a glucose-dependent manner.
Saxenda(®) was evaluated in the SCALE (Satiety and Clinical Adiposity -
Liraglutide Evidence) phase 3a clinical trial programme.
In the EU, Saxenda(®) is indicated as an adjunct to a reduced-calorie diet and
increased physical activity for weight management in adult patients with an
initial BMI of >30 kg/m(2 )(obese), or >27 kg/m(2) to <30 kg/m(2) (overweight)
in the presence of at least one weight-related comorbidity such as dysglycaemia
(pre-diabetes or type 2 diabetes), hypertension, dyslipidaemia or obstructive
sleep apnoea.
About Victoza(®)
Victoza(®) (liraglutide 1.2 mg and 1.8 mg) is a human glucagon-like peptide-1
(GLP-1) analogue with an amino acid sequence 97% similar to endogenous human
GLP-1. Victoza(®) was approved in the EU in 2009 and is commercially available
in more than 95 countries, treating more than 1 million people with type 2
diabetes globally. In Europe, Victoza(®) is indicated for the treatment of
adults with type 2 diabetes to achieve glycaemic control as monotherapy, when
metformin is considered inappropriate, and in combination with oral glucose-
lowering medicinal products and/or basal insulin when these, together with diet
and exercise, do not provide adequate glycaemic control. In the US, Victoza(®)
was approved in 2010 as an adjunct to diet and exercise to improve blood glucose
control in adults with type 2 diabetes.
About the LEADER trial
LEADER was a multicentre, international, randomised, double-blind, placebo-
controlled trial investigating the long-term (3.5-5 years) effects of Victoza(®)
(liraglutide 1.8 mg) compared to placebo, both in addition to standard of care,
in people with type 2 diabetes with established cardiovascular disease. Standard
of care was comprised of lifestyle modifications, glucose-lowering treatments
and cardiovascular medications.
LEADER was initiated in September 2010 and randomised 9,340 people with type 2
diabetes from 32 countries. The primary endpoint was the first occurrence of a
composite cardiovascular outcome comprising cardiovascular death, non-fatal
myocardial infarction or non-fatal stroke.
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 (USA) +1 609 235 8567 kpvj(at)novonordisk.com
Company announcement No 48 / 2017
PR170622_LEADER_EU_CHMP_Saxenda_UK:
http://hugin.info/2013/R/2115243/804852.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: 22.06.2017 - 20:20 Uhr
Sprache: Deutsch
News-ID 549476
Anzahl Zeichen: 6275
contact information:
Town:
Bagsvaerd
Kategorie:
Business News
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