Bagsværd, Denmark, 4 June 2021 – Novo Nordisk at present introduced that the US Meals and Drug Administration (FDA) has accredited Wegovy™ (the model identify for once-weekly semaglutide 2.4 mg injection within the US) for continual weight administration. Wegovy™ is indicated as an adjunct to weight loss program and train for continual weight administration in adults with weight problems (preliminary BMI≥30 kg/m2) or obese (preliminary BMI≥27 kg/m2) with at the very least one weight-related comorbidity.
Wegovy™ is the primary and solely once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist remedy accredited for weight administration for folks dwelling with weight problems. The approval is predicated on the outcomes from the STEP section 3a medical trial programme. Throughout the trials in folks with out sort 2 diabetes, a median weight lack of 17-18%1 sustained over 68 weeks was reported for folks with weight problems handled with Wegovy™. Wegovy™ demonstrated a secure and well-tolerated profile throughout the programme, with the most typical opposed occasions being gastrointestinal.
“The approval of Wegovy™ within the US brings nice promise to folks with weight problems. Regardless of the very best efforts to drop extra pounds, many individuals with weight problems battle to attain and keep weight reduction on account of physiological responses that favour weight regain,” stated Martin Holst Lange, government vice chairman, Improvement at Novo Nordisk. “The unprecedented weight reduction for an anti-obesity medicine marks a brand new period within the therapy of weight problems, and we now look ahead to making Wegovy™ out there to folks dwelling with weight problems within the US”.
Novo Nordisk expects to launch WegovyTM in america later in June 2021.
On 7 June at 8.30 CEST, comparable to 2.30 am EDT, a convention name for traders will likely be held. Traders will be capable to pay attention in by way of a hyperlink on the investor part of novonordisk.com.
About weight problems
Weight problems is a continual illness that requires long-term administration. It’s related to many critical well being problems and decreased life expectancy. Weight problems-related problems are quite a few and embody sort 2 diabetes, coronary heart illness, obstructive sleep apnoea, non-alcoholic fatty liver illness and sure forms of most cancers. The present COVID-19 pandemic has highlighted that weight problems additionally will increase the chance for extreme sickness and hospitalisation on account of COVID-19.
The worldwide improve within the prevalence of weight problems is a public well being concern that has extreme price implications to healthcare programs. Roughly 650 million adults are estimated to stay with weight problems worldwide.
About Wegovy™ (semaglutide 2.4 mg) and STEP
Semaglutide 2.4 mg is a GLP-1 receptor agonist, with 94% similarity to naturally occurring human GLP-1 hormone. It induces weight reduction by lowering starvation, rising feeling of fullness and thereby serving to folks eat much less and cut back their calorie consumption. As soon as-weekly semaglutide 2.4 mg injection is accredited for the therapy of adults with weight problems or obese within the US, along with weight loss program and train.
Semaglutide 2.4 mg for weight administration is at present beneath regulatory evaluate within the EU and different nations. The submissions are primarily based on the outcomes from the STEP (Semaglutide Remedy Impact in Individuals with weight problems) section 3 medical improvement programme. The worldwide medical section 3a programme consists of 4 trials and enrolled roughly 4,500 adults with obese or weight problems.
About Novo Nordisk
Novo Nordisk is a number one international healthcare firm, based in 1923 and headquartered in Denmark. Our objective is to drive change to defeat diabetes and different critical continual ailments similar to weight problems and uncommon blood and endocrine issues. We achieve this by pioneering scientific breakthroughs, increasing entry to our medicines and dealing to forestall and finally remedy illness. Novo Nordisk employs about 45,800 folks in 80 nations and markets its merchandise in round 170 nations. Novo Nordisk’s B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Inventory Alternate (NVO). For extra data, go to novonordisk.com, Facebook, Twitter, LinkedIn, YouTube.
Firm announcement No 38 / 2021
1 Primarily based on the trial product estimand (secondary statistical method): therapy impact if all folks adhered to therapy and didn’t provoke different anti-obesity therapies. When utilizing a therapy coverage estimand, 15-17% weight reduction was reported.