Novo Nordisk has announced that the Japanese Ministry of Health, Labour and Welfare 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.
The approval of Ozempic in Japan is based on results from the SUSTAIN clinical trial programme, 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.
“We are very excited about the approval of Ozempic in Japan, providing millions of people living with type 2 diabetes with a new and efficacious treatment option to help manage this complex disease,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer.
Novo Nordisk expects to launch Ozempic in Japan in the coming months, when reimbursement has been obtained.