Novo Nordisk submits application in the US for including data from the DEVOTE trial in the Tresiba® label - Seite 2

About DEVOTE

DEVOTE is a long-term, multi-centre, multi-national, randomised, double-blinded, parallel group and event-driven trial conducted to confirm the cardiovascular safety of Tresiba^® (insulin degludec) compared to insulin glargine U100. In the trial, 7,637 people with type 2 diabetes at high risk of cardiovascular disease were randomised to treatment with either Tresiba^® or insulin glargine U100 in vial in addition to standard of care.

The DEVOTE trial has been conducted in response to a Complete Response Letter received from the FDA in February 2013 requesting additional cardiovascular data from a dedicated cardiovascular outcomes trial before the review of the New Drug Applications for Tresiba^® and Ryzodeg^® 70/30 could be concluded. Tresiba^® and Ryzodeg^® 70/30 were approved in the US in September 2015 on the basis of an interim analysis of DEVOTE.

About Tresiba^®

Tresiba^® (insulin degludec) is a once-daily basal insulin that provides duration of action of at least 42 hours. Tresiba^® is taken once daily, at any time of day. Patients who miss or are delayed in taking their dose of Tresiba^® can take their dose as soon as they remember, but ensuring there are at least eight hours between doses. Tresiba^® received its first regulatory approval in September 2012 and has since been approved in more than 80 countries globally. It was approved by the US FDA in September 2015.

Further information

Media:
Katrine Sperling	[phone]	[e-mail]
Ken Inchausti (US)	[phone]	[e-mail]
Investors:
Peter Hugreffe Ankersen	[phone]	[e-mail]
Hanna Ögren	[phone]	[e-mail]
Anders Mikkelsen	[phone]	[e-mail]
Kasper Veje (US)	[phone]	[e-mail]

Company announcement No 39 / 2017