Novo Nordisk (NOVO) Status update summary

FDA approval and indication

• FDA approved once-weekly Wegovy (semaglutide 2.4 mg) for chronic weight management in US adults with obesity or overweight plus at least one weight-related comorbidity, alongside diet and exercise.

• First and only once-weekly GLP-1 receptor agonist approved for weight management; US launch expected later in June 2021.

Clinical results and safety

• In STEP phase 3a trials, participants with obesity without type 2 diabetes had average weight loss of 17–18% over 68 weeks under the trial product estimand; 15–17% under the treatment policy estimand.

• Safety profile was described as safe and well tolerated across the programme; most common adverse events were gastrointestinal.

Mechanism and regulatory progress

• Semaglutide 2.4 mg is a GLP-1 receptor agonist that reduces hunger and increases fullness; US approval covers adults with obesity or overweight, alongside diet and exercise.

• EU and other-country regulatory reviews were ongoing; submissions were based on the STEP phase 3 programme, comprising four trials and ~4,500 adults with overweight or obesity.