Novo Nordisk's Oral Wegovy for Weight Management Receives FDA Filing Acceptance

Danish pharmaceutical giant Novo Nordisk (NVO.US) announced that the U.S. Food and Drug Administration (FDA) has formally accepted the marketing application for its oral version of the weight-loss drug Wegovy and will make a decision in the fourth quarter.

If approved, this experimental once-daily oral formulation will become the world's first GLP-1 receptor agonist class oral drug for chronic weight management.

Boosted by this positive news, Novo Nordisk's closing stock price surged 5.53% to $69.23 in the U.S. market.

Currently, the company's marketed oral GLP-1 drug Rybelsus (active ingredient: semaglutide) has been approved for glycemic control in adult patients with diabetes.

In the injectable-dominated weight loss drug market, pharmaceutical companies such as Novo Nordisk and Eli Lilly are accelerating the development of more convenient oral weight loss medications. According to industry forecasts, the global obesity treatment market size is expected to exceed $150 billion in the coming years.

Last month, Eli Lilly (LLY.US) reported that clinical data for its experimental oral drug orforglipron showed that patients with type 2 diabetes lost an average of 16 pounds (approximately 7.3 kilograms), nearly 8% of their body weight, after 40 weeks of treatment.

The company will release another set of trial data for the drug's use in weight management later this year and plans to submit an application for the weight-loss indication to global regulatory authorities by the end of this year, while the diabetes indication application will be submitted next year.

Eli Lilly's marketed injectable tirzepatide is sold under the brands Mounjaro (for diabetes treatment) and Zepbound (for weight loss).

Novo Nordisk's current application is based on the results of a pivotal Phase III clinical trial. The study compared the efficacy differences between 25 mg oral semaglutide and placebo in 307 obese adult patients with at least one comorbidity.

In addition, the company is developing a new generation of weight-loss drug amycretin, which not only targets the intestinal hormone GLP-1 mimicked by Wegovy but also acts on amylin, a pancreatic hormone that regulates hunger. The subcutaneous injection formulation has now entered the trial stage.

Notably, investors have recently expressed concerns about Novo Nordisk facing fierce competition from Eli Lilly. Additionally, the clinical trial data for its next-generation weight-loss candidate drug, CagriSema, fell short of expectations, putting some pressure on the company. The drug was originally expected to become a potent alternative to Wegovy.

Editor: Yu Jian SF069