This article is more than 5 years old. Information may no longer be current.

Nova Nordisk submits NDA in Japan for semaglutide

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

A new drug application was submitted to Japanese Ministry of Health, Labour and Welfare for the once-weekly glucagon-like peptide-1 analogue semaglutide for treatment of adults with type 2 diabetes, according to a press release from Nova Nordisk.

The submission is based on results from the SUSTAIN trial of adults with type 2 diabetes (n = 8,000). Once-weekly semaglutide had superior results over other oral-antidiabetic agents or combination antidiabetic agents and insulin, as well as significant reductions in HbA1c and mean body weight. The most common adverse event in the SUSTAIN trial was nausea.

“We are very excited about having filed the regulatory application for once-weekly semaglutide in Japan,” Mads Krogsgaard Thomsen, executive vice president and chief scientific officer of Novo Nordisk, said in the release. “Based on the results from the global SUSTAIN clinical trial program, we believe that once-weekly semaglutide has the potential to improve the treatment for many type 2 patients in Japan.”

Regulatory submissions for semaglutide have also been submitted to the FDA, the European Medicines Agency, Health Canada and SwissMedic.