Novo Nordisk Seeks FDA Approval for High-Dose Wegovy Treatment

Novo Nordisk plans to seek US regulatory approval for a high-dose version of its weight-loss injection Wegovy (semaglutide), aiming to counter Eli Lilly's Zepbound. The company's chief scientific officer confirmed plans to submit an application to the FDA for approval, offering a similar weight-loss potential to Lilly's treatment.

Novo Nordisk, a leading Danish pharmaceutical company, has announced plans to seek US regulatory approval for a high-dose version of its weight-loss injection Wegovy (semaglutide). The company aims to counter Eli Lilly's recently launched Zepbound, which has shown significant weight-loss potential. The decision comes as Novo Nordisk's chief scientific officer confirmed that an application will be submitted to the FDA for approval, with the hope of offering a similar weight-loss potential to Lilly's treatment.

The high-dose version of Wegovy is being developed as part of Novo Nordisk's ongoing efforts to expand the use of semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1 RA). Semaglutide has already proven effective in reducing cardiovascular risk in people with type 2 diabetes, and the company is now exploring its potential in chronic weight management.

In a recent clinical trial, Novo Nordisk tested semaglutide at a dosage of 7.2 mg, which is three times the currently approved maximum dose of 2.4 mg. The results showed that patients lost an average of 19% of their body weight after 72 weeks, although this trailed behind Eli Lilly's tirzepatide, which reported an average weight loss of 22.5%. Despite this, experts suggested that, if competitively priced, the 7.2 mg semaglutide could represent a more affordable alternative.

Novo Nordisk's decision to seek US approval for the high-dose Wegovy follows the recent European Medicines Agency's (EMA) approval of oral semaglutide (Rybelsus) for its cardiovascular benefits in type 2 diabetes. This approval was based on the results of the SOUL trial, which demonstrated significant reductions in cardiovascular outcomes such as heart attack and stroke.

The company's efforts to expand the use of semaglutide reflect its strategic focus on developing innovative treatments for chronic conditions. As Novo Nordisk continues to push the boundaries of GLP-1 RA therapy, investors and financial professionals will be closely monitoring the outcomes of these regulatory submissions and their potential impact on the company's market position and financial performance.