Victoza® to be launched in Japan in June

Novo NordiskNovo Nordisk today announced that it has received approval of the price of Victoza®, a once-daily human GLP-1 analogue for the treatment of type 2 diabetes, from Japan's Central Social Insurance Medical Council (Chuikyo), the advisory committee to the Minister of Health, Labour and Welfare.

The price approval allows Novo Nordisk to commercially launch in Japan shortly after Victoza® is officially posted on Japan's National Health Insurance price list 11 June.

Victoza® is the first GLP-1 to achieve regulatory approval and commercial availability in Japan. It is indicated for the treatment of type 2 diabetes when used as monotherapy or as an add-on to sulphonylurea (SU).

Victoza® was approved by the Minister of Health, Labour and Welfare on 20 January 2010 based on a clinical development programme specifically tailored to the needs of people with type 2 diabetes in Japan.

About Victoza®
Victoza® is the only human GLP-1 analogue; it has 97% homology to natural GLP-1. Like natural GLP-1, Victoza® (liraglutide) works by stimulating the beta cells to release insulin only when blood sugar levels are high. Due to this glucose-dependent mechanism of action, Victoza® is associated with a low rate of hypoglycaemia. The mechanism of blood sugar lowering also involves a delay in gastric emptying.

Victoza® was approved by the US Food and Drug Administration (FDA) on 25 January 2010 as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes.

Victoza® was approved by the European Commission in all 27 European Union member states on 30 June 2009. As of May 2010, approval has also been granted by the regulatory authorities in Japan, Norway, Mexico, Iceland, Switzerland, Lebanon, India, Macedonia, Brazil, Canada, Croatia, Argentina, Qatar and Russia. Victoza® has already been commercially launched in the US and Canada as well as the UK, Germany and Denmark and a number of other European countries; it will be available in other markets throughout 2010. A New Drug Application was also submitted for approval in China in August 2009. A regulatory decision is pending.

About Novo Nordisk
Headquartered in Denmark, Novo Nordisk is a global healthcare company with 87 years of innovation and leadership in diabetes care. The company also has leading positions within haemophilia care, growth hormone therapy and hormone replacement therapy. For more information, visit novonordisk.com.

Most Popular Now

Bayer, Brigham and Women’s Hospital, and Massachus…

Bayer and Partners HealthCare's founding members Brigham and Women's Hospital (BWH) and Massachusetts General Hospital (MGH) today announced the launch of a joint lab to ...

AstraZeneca divests rights for Losec to Cheplaphar…

AstraZeneca has agreed to sell the global commercial rights, excluding China, Japan, the US and Mexico, for Losec (omeprazole) and associated brands to Cheplapharm Arznei...

Cause of antibiotic resistance identified

Scientists have confirmed for the first time that bacteria can change form to avoid being detected by antibiotics in the human body. Studying samples from elderly patient...

Amgen announces positive results from two Phase 3 …

Amgen (NASDAQ:AMGN) today announced that the results of a prespecified interim analysis of an open-label, randomized, controlled global multicenter Phase 3 trial (2012021...

Brilinta monotherapy in high-bleeding risk patient…

New data from TWILIGHT, a Phase IV independent trial (funded by AstraZeneca), showed that in patients at high-bleeding risk who underwent PCI and completed 3 months of du...

Novartis and Microsoft announce collaboration to t…

Novartis announced an important step in reimagining medicine by founding the Novartis AI innovation lab and by selecting Microsoft as its strategic AI and data-science pa...

Ian Read to retire as Executive Chairman of Pfizer…

Following its regularly scheduled meeting, the Board of Directors of Pfizer Inc. (NYSE:PFE) today announced that Executive Chairman of the Board Ian C. Read has chosen to...

FDA approves first oral GLP-1 treatment for type 2…

The U.S. Food and Drug Administration today approved Rybelsus (semaglutide) oral tablets to improve control of blood sugar in adult patients with type 2 diabetes, along w...

Discovery of new source of cancer antigens may exp…

For more than a decade, scientist Stephen Albert Johnston and his team at Arizona State University's Biodesign Institute have pooled their energies into an often scoffed-...

Chinese activists protest the use of traditional t…

In the West, the number of people challenging scientific authority has been growing in past decades. This has, among other things, led to a decline in the support for mas...

Cheaper drug just as effective protecting heart in…

A new clinical trial conducted at The Ohio State University Wexner Medical Center found a cost-effective generic medication works just as well as a more expensive drug in...

Dengue virus becoming resistant to vaccines and th…

Researchers from Duke-NUS Medical School (DukeNUS), in collaboration with the Agency for Science, Technology and Research (A*STAR)'s Bioinformatics Institute (BII), and t...