Diabetes drug Ozempic approved in Japan

Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved Ozempic(semaglutide), a new once-weekly analogue of human glucagon-like peptide-1 (GLP-1),for the treatment of adults with type 2 diabetes.

Danish diabetes care giant Novo Nordisk (NOV: N), whose shares edged up 0.85% to 295.75 kroner by mid-morning, expects to launch Ozempic in Japan in the coming months, when reimbursement has been obtained.

Ozempic was first approved in the USA in December 2017 and was launched there in February this year, when it also gained approval from the European Commission. Analysts on average expect annual sales of Ozempic to reach $3.17 billion by 2023.

The approval of Ozempicin Japan is based on results from the SUSTAIN clinical trial program, which involved more than 8,000 adults with type 2 diabetes. The approval is based on the results from five SUSTAIN trials, including approximately 1,200 adults from Japan. 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.