Skip to main content

Ozempic® 2.0 mg approved in the US for the treatment of type 2 diabetes

Written by Customer Service on . Posted in Public Companies.

Bagsværd, Denmark, 28 March 2022 – Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved a 2.0 mg dose of Ozempic® (once-weekly semaglutide subcutaneous injection), a glucagon-like peptide-1 (GLP-1) analogue for the treatment of adults with type 2 diabetes. Ozempic® is now approved in the US at 0.5 mg,1.0 mg and 2.0 mg doses for the treatment of type 2 diabetes in adults. Further, Ozempic® is indicated to reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes and known heart disease.

The FDA approval is based on the results from the SUSTAIN FORTE trial. In the trial, people treated with semaglutide 2.0 mg achieved a statistically significant and superior reduction in HbA1c at week 40 compared to semaglutide 1.0 mg. In the trial, both doses of semaglutide appeared to have a safe and well-tolerated profile. The most common adverse events were gastrointestinal. Compared to semaglutide 1.0 mg, the gastrointestinal adverse events were similar for semaglutide 2.0 mg. 

“We are pleased with the FDA approval for a higher 2.0 mg dose of Ozempic®, which further supports our purpose of driving change in diabetes care” said Martin Lange, executive vice president, Development at Novo Nordisk. “The approval of the 2.0 mg dose allows more people with type 2 diabetes to achieve and maintain individualised glycaemic targets and remain on the same medication for longer as their needs evolve.”

Novo Nordisk expects to launch Ozempic® 2.0 mg in the United States in the second quarter of 2022. Ozempic® 2.0 mg is now approved in the US, the EU, Canada and Switzerland.

About the SUSTAIN clinical programme
The SUSTAIN clinical development programme for once-weekly subcutaneous semaglutide injection currently comprises 11 phase 3 global clinical trials, including a cardiovascular outcomes trial, involving more than 11,000 adults with type 2 diabetes. For more information about the SUSTAIN FORTE trial, please read the headline results here.

About Novo Nordisk
Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 47,800 people in 80 countries and markets its products in around 170 countries. Novo Nordisk’s B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn and YouTube.

Further information

Media:  
Ambre Brown Morley+45 3079 9289abmo@novonordisk.com
Michael Bachner (US)  +1 609 664 7308 mzyb@novonordisk.com 
   
Investors:   
Daniel Muusmann Bohsen +45 3075 2175 dabo@novonordisk.com 
Ann Søndermølle Rendbæk +45 3075 2253 arnd@novonordisk.com 
David Heiberg Landsted +45 3077 6915 dhel@novonordisk.com 
Jacob Martin Wiborg Rode+45 3075 5956jrde@novonordisk.com
Mark Joseph Root (US) +1 848 213 3219 mjhr@novonordisk.com 

Company announcement No 27 / 2022

 

Attachment

Disclaimer & Cookie Notice

Welcome to GOLDEA services for Professionals

Before you continue, please confirm the following:

Professional advisers only

I am a professional adviser and would like to visit the GOLDEA CAPITAL for Professionals website.

Important Notice for Investors:

The services and products offered by Goldalea Capital Ltd. are intended exclusively for professional market participants as defined by applicable laws and regulations. This typically includes institutional investors, qualified investors, and high-net-worth individuals who have sufficient knowledge, experience, resources, and independence to assess the risks of trading on their own.

No Investment Advice:

The information, analyses, and market data provided are for general information purposes only and do not constitute individual investment advice. They should not be construed as a basis for investment decisions and do not take into account the specific investment objectives, financial situation, or individual needs of any recipient.

High Risks:

Trading in financial instruments is associated with significant risks and may result in the complete loss of the invested capital. Goldalea Capital Ltd. accepts no liability for losses incurred as a result of the use of the information provided or the execution of transactions.

Sole Responsibility:

The decision to invest or not to invest is solely the responsibility of the investor. Investors should obtain comprehensive information about the risks involved before making any investment decision and, if necessary, seek independent advice.

No Guarantees:

Goldalea Capital Ltd. makes no warranties or representations as to the accuracy, completeness, or timeliness of the information provided. Markets are subject to constant change, and past performance is not a reliable indicator of future results.

Regional Restrictions:

The services offered by Goldalea Capital Ltd. may not be available to all persons or in all countries. It is the responsibility of the investor to ensure that they are authorized to use the services offered.

Please note: This disclaimer is for general information purposes only and does not replace individual legal or tax advice.