Having filed submissions in the USA, Canada and Europe, Danish diabetes giant Novo Nordisk (NOV: N) has now set its sights on Japan as it seeks to gain approval for semaglutide, a glucagon-like peptide-1 (GLP-1) analogue administrated once-weekly, for the treatment of adults with type 2 diabetes.
The company has submitted a New Drug Application for the treatment to the Japanese Ministry of Health, Labor and Welfare based on results from the SUSTAIN clinical trial program involving more than 8,000 adults with type 2 diabetes, including around 1,200 participants from Japan.
Study participants were treated with once-weekly semaglutide as monotherapy, or with oral-antidiabetic (OAD) agents or in combination with OADs and basal insulin.
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