Ozempic® approved in Japan for the treatment of type 2 diabetes
Bagsværd, Denmark, 23 March 2018 - Novo Nordisk today 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.
Ozempic® (semaglutide) is a new once-weekly analogue of human glucagon-like peptide-1 (GLP-1) that has been developed for the treatment of type 2 diabetes. The approval of Ozempic® is based on the SUSTAIN programme, a global clinical development programme that comprises six global and two Japanese phase 3a trials, encompassing more than 8,000 adults with type 2 diabetes. Ozempic® was approved by the US FDA on 5 December 2017, by Health Canada on 4 January 2018 and by the European Commission on 9 February 2018.
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Company announcement No 26 / 2018