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Press Release

Ozempic® approved in Japan for the treatment of type 2 diabetes

Novo Nordisk A/S
Posted on: 23 Mar 18

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

Katrine Sperling+45 3079 6718
Ken Inchausti (US)+1 609 786 8316
Investors :    
Peter Hugreffe Ankersen+45 3075 9085
Anders Mikkelsen+45 3079 4461
Christina Kjær+45 3079 3009

 Company announcement No 26 / 2018


PR180323_Ozempic_JP_ approval_UK

This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.

The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: Novo Nordisk A/S via GlobeNewswire

Last updated on: 24/03/2018

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