Novo Nordisk receives positive 17-2 vote from FDA Advisory Committee that Victoza® provides substantial evidence of cardiovascular risk reduction in patients with type 2 diabetes
(Thomson Reuters ONE) -
Bagsværd, Denmark, 20 June 2017 - Novo Nordisk today announced that
the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the US Food
and Drug Administration (FDA) has completed its meeting regarding the
supplemental New Drug Application (sNDA) for inclusion of the data from the
cardiovascular outcomes trial LEADER in the label for Victoza(®) (liraglutide).
The discussions at the Advisory Committee meeting were based on data from the
LEADER trial, which involved more than 9,300 people with type 2 diabetes at high
risk of major cardiovascular events.
The Advisory Committee voted 19-0 in favour of Victoza(®) on the question: "Do
the results of LEADER establish that use of Victoza(®) in patients with type 2
diabetes is not associated with excess cardiovascular risk?"
The Advisory Committee voted 17-2 in favour of Victoza(®) on the question: "Does
the LEADER trial provide the substantial evidence needed to establish that
Victoza(®) (liraglutide 1.8 mg) reduces cardiovascular risk in patients with
type 2 diabetes?"
"Cardiovascular disease is the number one cause of death for people with type 2
diabetes," said Mads Krogsgaard Thomsen, executive vice president and chief
science officer of Novo Nordisk. "With the positive vote today, we are excited
to be one step closer towards a cardiovascular indication for Victoza(®) to
reduce the risk of cardiovascular events in people with type 2 diabetes. We look
forward to working with the FDA to include the important results from the LEADER
trial in the Victoza(®) label."
The supplemental New Drug Application for Victoza(®) was submitted to the FDA in
October 2016 and regulatory feedback in the US is expected in Q3 2017. In
Europe, a Type II Variation application was submitted to the European Medicines
Agency (EMA) in October 2016.
Conference call
On 21 June 2017 at 8.00 am CEST (2.00 am EDT), Novo Nordisk will host a
conference call for investors. Investors will be able to listen in via a link on
the investor section of novonordisk.com/investors.
About advisory committees
FDA advisory committees are panels of independent experts who advise the FDA on
specific questions raised by the FDA as they consider regulatory decisions. The
FDA is not bound by the committee''s recommendation, but it takes its advice into
consideration when reviewing data concerning the safety and effectiveness of
marketed or new drug applications.
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 up to 1.8 mg) compared to placebo, both in addition to standard of
care, in people with type 2 diabetes at high risk of major cardiovascular
events. 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.
About Victoza(®)
Victoza(®) (liraglutide) injection 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 90 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.
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 47 / 2017
PR170620_LEADER_Adcom_UK:
http://hugin.info/2013/R/2114627/804599.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
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Datum: 20.06.2017 - 17:58 Uhr
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