Tag: 1492

Bagsværd, Denmark, 23 June 2025 – Novo Nordisk today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for an update of the Ozempic^® (once-weekly semaglutide) label to reflect the positive data from the STRIDE peripheral artery disease (PAD) functional outcomes trial.

Bagsværd, Denmark, 22 June 2025 – Novo Nordisk today presented results from the phase 3b FRONTIER5 trial showing that a direct switch to investigational Mim8 (denecimig) prophylaxis from emicizumab treatment, without a washout period or Mim8 loading dose, was well-tolerated with no safety concerns in adults and adolescents living with haemophilia A, with or without inhibitors¹. Additionally, a FRONTIER5 Patient-Reported Outcomes (PROs) assessment found the Mim8 pen-injector easy to use, with an overall strong user preference for the pen-injector compared to the previous emicizumab injection system^2,3. The results were presented at the International Society on Thrombosis and Haemostasis (ISTH) Congress in Washington, D.C.

Bagsværd, Denmark, 22 June – Today, The New England Journal of Medicine (NEJM) published results from Novo Nordisk’s phase 3 REDEFINE 1 trial evaluating the efficacy and safety of investigational CagriSema plus lifestyle interventions for weight loss in adults with obesity or overweight who have a weight-related medical complication and without diabetes.¹ REDEFINE 1 met its co-primary endpoints and achieved statistically significant and clinically meaningful weight loss at 68 weeks in patients taking CagriSema versus placebo.¹ These data, along with the related phase 3 REDEFINE 2 study conducted in adults with overweight or obesity and type 2 diabetes, were presented today during a scientific symposium at the American Diabetes Association’s (ADA) 85th Scientific Sessions and published in NEJM.

Higher dose of Wegovy^® provided average weight loss of 21% in people with obesity – with a third achieving 25% or more – according to data presented at ADA

Bagsværd, Denmark, 20 June 2025 – Novo Nordisk announces subcutaneous amycretin data being presented at the American Diabetes Association (ADA) 85^th Scientific Sessions in Chicago, US.¹ Full results of two clinical trials evaluating the safety, tolerability and weight loss potential of subcutaneous and oral amycretin in people with overweight or obesity were published today in The Lancet medical journal.^1,3 Amycretin is the first treatment that combines GLP-1 and amylin receptor agonism biology in a single molecule.