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 HbA_1c 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.

About Ozempic^®

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.

Further information

 Company announcement No 26 / 2018