Novo Nordisk plans summer launches for new diabetes drug
pharmafile | May 7, 2009 | News story | Research and Development, Sales and Marketing |Â Â Novo Nordisk, Victoza, diabetesÂ
Novo Nordisk is preparing Victoza for a summer launch into its first European markets, including the UK, after it was recently recommended for approval.
Victoza (liraglutide) is the first once-daily Glucagon-like peptide-1 (GLP-1) analogue developed for type 2 diabetes.
Final marketing authorisation from the European Commission is expected within the next couple of months following a positive opinion from the Committee for Medicinal Products for Human Use.
"We are optimistic that Victoza will soon be approved for patients with type 2 diabetes," said Viggo Birch, managing director of Novo Nordisk UK and Ireland.
The drug, which works both by stimulating the release of insulin when glucose levels become too high, and by reducing appetite, will then be launched in "selected" European markets including the UK.
There are currently several GLP-1 drugs in development, but the class has picked up some safety concerns.
The US Food and Drug Administration has already expressed concern with Victoza after some rodents developed thyroid cancer during clinical studies.
Victoza will rival Lilly's Byetta (exanatide) and is expected to face stronger competition if the once-weekly injectable version of Byetta currently in development is approved.
The twice-daily version of Lilly's drug, launched in 2005, ran into problems last year after it was linked with fatal pancreatitis in a handful of patients.
Another potential rival in development is GlaxoSmithKline's Syncria (albiglutide) and, if successful, this may need be injected less than once a week. Syncria's point of difference from Novo Nordisk's and Lilly's analogues is that it fuses human GLP-1 to human albumin.
Victoza is recommended for approval in combination with metformin or a sulphonylurea in patients with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin or sulphonylurea.
It can also be given with metformin and a sulphonylurea or metformin and a thiazolidinedione in patients with insufficient glycaemic control despite dual therapy.
Professor Steve Gough at Birmingham's Selly Oak Hospital, said: "There is no doubt that there is a great unmet need for a treatment with Victoza's benefits and physicians in the UK are very encouraged by [the] data."
As well as a New Drug Application (NDA) to the FDA and marketing authorisation application to the European Medicines Agency, Novo Nordisk has also submitted an NDA in Japan last year. A decision on that is expected in 2010.
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