Novo Nordisk’s type two diabetes treatment for adults approved in japanMarch 23, 2018
The Japanese Ministry of Health, Labour and Welfare has approved Novo Nordisk’s treatment for type 2 diabetes adult patients, new once-weekly analogue of human glucagon-like peptide-1 (GLP-1) Ozempic.
The diabetes specialist Novo Nordisk got Ozempic’s approval by the US FDA in December 2017, by Health Canada in January 2018 and by the European Commission in February 2018.
Japan has approved Ozempic after testing in on more than 8,000 patients in the SUSTAIN clinical trial programme of five SUSTAIN trials, including about 1,200 adults from Japan. Novo Nordisk said Friday, in the announcement of the approval, that the approved label reflects that treatment with Ozempic resulted in greater reductions in HbA1c relative to comparator treatments, as well as greater reductions in mean body weight achieved with Ozempic in Japanese people compared to placebo in the two SUSTAIN monotherapy trials.
Novo Nordisk will aim for millions of patients living with type 2 diabetes in Japan, noted Mads Krogsgaard Thomsen, chief science officer. Thomsen said Ozempic should be a new and efficacious treatment option to help manage this complex disease.
Novo Nordisk said it could launch Ozempic in Japan in the coming months.