Regulatory Approval

(Thomson Reuters ONE) - Novo Nordisk receives US approval for Victoza® (liraglutide) for the treatmentof type 2 diabetesNovo Nordisk announced today that the US Food and Drug Administration (FDA) hasgranted marketing authorisation for Victoza® for the treatment of type 2diabetes in adults.Victoza® is the brand name approved in the US and Europe for liraglutide, thefirst once-daily human Glucagon-Like Peptide-1 (GLP-1) analogue developed forthe treatment of type 2 diabetes. In the US, Victoza® is indicated as an adjunctto diet and exercise to improve glycaemic control in adults with type 2diabetes. This provides for Victoza® to be used in monotherapy, as second-linetreatment and in combination with commonly prescribed oral medications fordiabetes."The US approval of Victoza® represents a major advancement in the treatment oftype 2 diabetes and is an important milestone for Novo Nordisk that follows therecent approval in Japan and the ongoing successful launch in Europe." says LarsRebien S?sen, president and CEO. "We are convinced that Victoza® will proveto be a valuable treatment option for people with type 2 diabetes in the US. Theability of Victoza® to substantially improve glucose control with a low risk ofhypoglycaemia creates an opportunity for more patients with type 2 diabetes toachieve 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 formedthe 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 incombination with one or two oral antidiabetic medications and showed better orequivalent lowering of blood glucose than active comparators such assulphonylureas and thiazolidinediones.Unlike many other diabetes medications, Victoza® is not associated with weightgain. For patients with type 2 diabetes, clinical trial data demonstrate areduction in body weight in the LEAD(TM) programme. Body weight was a secondaryendpoint in the clinical development trials.The most common adverse events reported during the clinical developmentprogramme in patients treated with Victoza® were associated with thegastrointestinal system. Gastrointestinal adverse events, including nausea,vomiting and diarrhoea were reported most frequently in the early part of thetreatment period with Victoza® and few patients withdrew due to these adverseevents.Important safety informationThe US prescribing information includes a boxed warning for the risk of thyroidc-cell tumours. In preclinical testing, Victoza® caused thyroid c-cell tumoursin rodents. In clinical trials there were no reported cases of medullary thyroidcarcinoma (MTC) in patients treated with Victoza®, but human relevance of therodent findings could not be ruled out by clinical or non-clinical studies.Victoza® is contraindicated in patients with a personal or family history of MTCor Multiple Endocrine Neoplasia syndrome type 2.The marketing authorisation further includes a risk evaluation and mitigationstrategy (REMS) programme comprised of a Medication Guide to patients and aCommunication Plan directed at healthcare providers - both informing about therisk of pancreatitis and the potential risk of MTC.Conference callOn 26 January 2010 at 08:00 am CET, corresponding to 02:00 am EST, a conferencecall for investors will be held. Investors will be able to listen in via a linkon the investor section ofnovonordisk.com .Presentation material for the conference call will be made availableapproximately one hour before on the same page, and a replay of the conferencecall will be available approximately two hours after its conclusion.About Victoza®Once-daily Victoza® is the first human Glucagon-Like Peptide-1 (GLP-1) analoguedeveloped for the treatment of type 2 diabetes. Victoza® works by stimulatingthe release of insulin from the pancreatic beta cells only when blood sugarlevels are high. Clinical trial data demonstrate a reduction in body weight.Victoza® is broken down naturally in the body and does not depend upon renalexcretion.In Europe, Novo Nordisk received marketing authorisation for Victoza® on 30 Juneand Victoza® has subsequently been launched in the UK, Germany, Denmark, Norwayand Ireland. In Japan, Novo Nordisk received marketing authorisation forVictoza® on 20 January 2010. A regulatory decision is pending in China where aNew Drug Application was submitted in August 2009.Novo Nordisk is a healthcare company and a world leader in diabetes care. Inaddition, Novo Nordisk has a leading position within areas such as haemostasismanagement, growth hormone therapy and hormone replacement therapy. Novo Nordiskmanufactures and markets pharmaceutical products and services that make asignificant difference to patients, the medical profession and society. Withheadquarters in Denmark, Novo Nordisk employs more than 29,000employees in 81countries, and markets its products in 179 countries. Novo Nordisk's B sharesare listed on the stock exchanges in Copenhagen and London. Its ADRs are listedon the New York Stock Exchange under the symbol 'NVO'. For more information,visit novonordisk.com.Further information: Media: Investors: Katrine Sperling Klaus B? Davidsen Tel: (+45) 3079 6718 Tel: (+45) 4442 3176 krsp(at)novonordisk.com klda(at)novonordisk.com Kasper Roseeuw Poulsen Tel: (+45) 4442 4471 krop(at)novonordisk.com In North America: In North America: An Phan Hans Rommer Tel: (+1) 609 558 0420 Tel: (+1) 609 919 7937 anph(at)novonordisk.com hrmm(at)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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Datum: 25.01.2010 - 20:15 Uhr
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