Novo Nordisk to Seek FDA Approval for High-Dose Wegovy

Novo Nordisk plans to seek US approval for a high-dose version of its weight-loss shot Wegovy, competing with Eli Lilly's Zepbound. The high-dose version offers the same weight-loss potential as Zepbound, providing patients with another option. Novo is building out a portfolio of semaglutide compounds, including a pill version of Wegovy and a higher-dose shot. The company aims to regain its leading position in the obesity market.

Novo Nordisk A/S has announced plans to seek US approval for a high-dose version of its weight-loss medication Wegovy, aiming to compete with Eli Lilly's Zepbound. This high-dose version of semaglutide is expected to offer the same weight-loss potential as Zepbound, providing patients with an additional treatment option. The announcement comes as Novo Nordisk expands its portfolio of semaglutide compounds, including a pill version of Wegovy and a higher-dose shot. The company aims to regain its leading position in the obesity market.

Novo Nordisk's strategic move follows the recent approval of its oral semaglutide, Rybelsus, by the European Medicines Agency (EMA) for type 2 diabetes with proven cardiovascular benefits Novo Nordisk's Rybelsus Now First Oral GLP-1 RA In Europe With Proven Heart Health Impact^[1]. Rybelsus, launched in 2019, is the first and only oral glucagon-like peptide 1 receptor agonist (GLP-1 RA) with such benefits in the EU. The approval is based on results from the SOUL clinical trial, where oral semaglutide reduced cardiovascular death, heart attack, and stroke by 14% versus placebo in high-risk type 2 diabetes patients Novo Nordisk's Rybelsus Now First Oral GLP-1 RA In Europe With Proven Heart Health Impact^[1].

In addition to the high-dose version of Wegovy, Novo Nordisk has submitted an application in the US for a once-daily 25 mg oral formulation of semaglutide for adult patients with obesity or overweight and cardiovascular disease. A decision is expected at the turn of this year, and if approved, Wegovy would become the first oral GLP-1 RA indicated for chronic weight management Novo Nordisk's Rybelsus Now First Oral GLP-1 RA In Europe With Proven Heart Health Impact^[1].

Novo Nordisk's efforts to expand its semaglutide portfolio align with the company's goal of addressing the growing obesity epidemic. The high-dose version of Wegovy and the oral formulation are part of the company's broader strategy to offer innovative solutions for chronic diseases, including type 2 diabetes and obesity.