Novo Nordisk plans to apply for U.S. regulatory approval for high-dose Wegovy

According to Zhitong Finance APP, Novo Nordisk (NVO.US) plans to apply for U.S. regulatory approval for a high-dose version of its blockbuster weight loss therapy "Wegovy." This is another significant move by the company to combat its rival Eli Lilly (LLY.US) in the booming obesity treatment market. Novo Nordisk's Chief Scientific Officer Martin Holst Lange stated that the high-dose Wegovy has weight loss potential comparable to Eli Lilly's Zepbound, providing new treatment options for patients. He revealed on Tuesday at the European Association for the Study of Diabetes meeting in Vienna that while the company has not officially announced its plans for the U.S. market, it has confirmed that it will submit an approval application to the U.S. Food and Drug Administration (FDA). "Clearly, our competitors have optimized their dosing," Lange said in an interview. "Now, we have achieved the same goal with high-dose Wegovy." Wegovy and another Novo Nordisk drug, Ozempic, share the same active ingredient, semaglutide. Currently, Novo Nordisk is building a diversified product portfolio around this ingredient, which includes not only high-dose injectables but also an oral tablet version of Wegovy. As a pioneer in the obesity treatment market, Novo Nordisk is now attempting to regain its industry-leading position through product positioning, having previously lost some market share to Eli Lilly in the critical U.S. market. Earlier this year, Novo Nordisk submitted an application for high-dose Wegovy in Europe. Additionally, Novo Nordisk reiterated its plan to conduct late-stage clinical trials for the experimental compound cagrilintide. This compound has a different mechanism of action than semaglutide and is derived from another type of gut hormone. Notably, Novo Nordisk's next-generation obesity therapy CagriSema previously underperformed in a large study; the company is currently planning to adjust its R&D strategy by separately testing the efficacy of cagrilintide while optimizing the positioning of CagriSema through new clinical trials