NVOB Novo-N.Dkk1'b'

 
TIDMNVOB 
 
Novo Nordisk receives US approval for Victoza ® (liraglutide) for the treatment 
of type 2 diabetes 
 
Novo Nordisk announced today that the US Food and Drug Administration (FDA) has 
granted marketing authorisation for Victoza ® for the treatment of type 2 
diabetes in adults. 
 
Victoza ® is the brand name approved in the US and Europe for liraglutide, the 
first once-daily human Glucagon-Like Peptide-1 (GLP-1) analogue developed for 
the treatment of type 2 diabetes. In the US, Victoza ® is indicated as an adjunct 
to diet and exercise to improve glycaemic control in adults with type 2 
diabetes. This provides for Victoza ® to be used in monotherapy, as second-line 
treatment and in combination with commonly prescribed oral medications for 
diabetes. 
 
"The US approval of Victoza ® represents a major advancement in the treatment of 
type 2 diabetes and is an important milestone for Novo Nordisk that follows the 
recent approval in Japan and the ongoing successful launch in Europe." says Lars 
Rebien Sørensen, president and CEO. "We are convinced that Victoza ® will prove 
to be a valuable treatment option for people with type 2 diabetes in the US. The 
ability of Victoza ® to substantially improve glucose control with a low risk of 
hypoglycaemia creates an opportunity for more patients with type 2 diabetes to 
achieve their individual treatment goals." 
 
Novo Nordisk expects to introduce Victoza ® in the US market within weeks. 
 
Clinical results: LEAD(TM) (Liraglutide Effect and Action in Diabetes) 
 
The Victoza ® phase 3 clinical trial programme, entitled LEAD(TM), which formed 
the basis of the regulatory submission, is comprised of randomised, controlled, 
double-blinded studies comparing Victoza ® to commonly prescribed treatments. 
These multinational trials evaluated Victoza ® in monotherapy as well as in 
combination with one or two oral antidiabetic medications and showed better or 
equivalent lowering of blood glucose than active comparators such as 
sulphonylureas and thiazolidinediones. 
 
Unlike many other diabetes medications, Victoza ® is not associated with weight 
gain. For patients with type 2 diabetes, clinical trial data demonstrate a 
reduction in body weight in the LEAD(TM) programme. Body weight was a secondary 
endpoint in the clinical development trials. 
 
The most common adverse events reported during the clinical development 
programme in patients treated with Victoza ® were associated with the 
gastrointestinal system. Gastrointestinal adverse events, including nausea, 
vomiting and diarrhoea were reported most frequently in the early part of the 
treatment period with Victoza ® and few patients withdrew due to these adverse 
events. 
 
Important safety information 
 
The US prescribing information includes a boxed warning for the risk of thyroid 
c-cell tumours. In preclinical testing, Victoza ® caused thyroid c-cell tumours 
in rodents. In clinical trials there were no reported cases of medullary thyroid 
carcinoma (MTC) in patients treated with Victoza ®, but human relevance of the 
rodent findings could not be ruled out by clinical or non-clinical studies. 
Victoza ® is contraindicated in patients with a personal or family history of MTC 
or Multiple Endocrine Neoplasia syndrome type 2. 
 
The marketing authorisation further includes a risk evaluation and mitigation 
strategy (REMS) programme comprised of a Medication Guide to patients and a 
Communication Plan directed at healthcare providers - both informing about the 
risk of pancreatitis and the potential risk of MTC. 
 
Conference call 
 
On 26 January 2010 at 08:00 am CET, corresponding to 02:00 am EST, a conference 
call for investors will be held. Investors will be able to listen in via a link 
on the investor section ofnovonordisk.com <http://www.novonordisk.com/>. 
Presentation material for the conference call will be made available 
approximately one hour before on the same page, and a replay of the conference 
call will be available approximately two hours after its conclusion. 
 
About Victoza ® 
 
Once-daily Victoza ® is the first human Glucagon-Like Peptide-1 (GLP-1) analogue 
developed for the treatment of type 2 diabetes. Victoza ® works by stimulating 
the release of insulin from the pancreatic beta cells only when blood sugar 
levels are high. Clinical trial data demonstrate a reduction in body weight. 
Victoza ® is broken down naturally in the body and does not depend upon renal 
excretion. 
 
In Europe, Novo Nordisk received marketing authorisation for Victoza ® on 30 June 
and Victoza ® has subsequently been launched in the UK, Germany, Denmark, Norway 
and Ireland. In Japan, Novo Nordisk received marketing authorisation for 
Victoza ® on 20 January 2010. A regulatory decision is pending in China where a 
New Drug Application was submitted in August 2009. 
 
Novo Nordisk is a healthcare company and a world leader in diabetes care. In 
addition, Novo Nordisk has a leading position within areas such as haemostasis 
management, growth hormone therapy and hormone replacement therapy. Novo Nordisk 
manufactures and markets pharmaceutical products and services that make a 
significant difference to patients, the medical profession and society. With 
headquarters in Denmark, Novo Nordisk employs more than 29,000employees in 81 
countries, and markets its products in 179 countries. Novo Nordisk's B shares 
are listed on the stock exchanges in Copenhagen and London. Its ADRs are listed 
on the New York Stock Exchange under the symbol 'NVO'. For more information, 
visit novonordisk.com. 
 
Further information: 
 
 
 Media:                                  Investors: 
 
 
 
 Katrine Sperling                        Klaus Bülow Davidsen 
 
 Tel: (+45) 3079 6718                    Tel: (+45) 4442 3176 
 
 krsp@novonordisk.com                    klda@novonordisk.com 
 <mailto:krsp@novonordisk.com>           <mailto:klda@novonordisk.com> 
 
 
                                         Kasper Roseeuw Poulsen 
 
                                         Tel: (+45) 4442 4471 
 
                                         krop@novonordisk.com 
                                         <mailto:krop@novonordisk.com> 
 
 
 In North America:                       In North America: 
 
 An Phan                                 Hans Rommer 
 
 Tel: (+1) 609 558 0420                  Tel: (+1) 609 919 7937 
 
 anph@novonordisk.com                    hrmm@novonordisk.com 
 <mailto:anph@novonordisk.com>           <mailto:hrmm@novonordisk.com> 
 
 
Company Announcement no 3 / 2010 
 
 
 
[HUG#1377004] 
 
 
 
 
 
    Company Announcement no 3 2010: http://hugin.info/2013/R/1377004/338120.pdf 
 

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