While still waiting for the nod from US regulators, Novo Nordisk is celebrating the news that Japan has approved its diabetes drug Victoza.
The Japanese Ministry of Health, Labour and Welfare has given the green light to Victoza (liraglutide), which belongs to the much-talked about glucagon-like peptide-1 analogue class of the drugs. It is the first GLP-1 drug to be approved in Japan and the once-daily injectable is indicated as monotherapy or as an add-on to sulphonylurea in people with type 2 diabetes
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The Japanese approval “represents a major advancement” and “an important milestone for Novo”, said chief excientific officer Mads Krogsgaard Thomsen. He added that “we are excited to pioneer the GLP-1 market in Japan”, noting that clinical studies conducted in Japan showed Victoza provides “superior glucose control with a low risk of hypoglycaemia”.
The drug has been available in Europe since last summer and Novo expects to launch it in Japan in the first half of 2010 “upon completion of price negotiations”. The Danish drugmaker is still waiting to hear from the US Food and Drug Administration which has been dragging its heels over approving the treatment.
The agency is expected to complete its review soon and if approved, Victoza will compete with Amylin/Eli Lilly’s blockbuster GLP-1 analogue Byetta (exenatide).
