Novo Nordisk A/S Sponsored ADR Class B (NVO.US) plans to apply for US regulatory approval for the high-dose Wegovy.
Novo Nordisk (NVO.US) plans to seek regulatory approval in the United States for a high-dose version of its blockbuster weight-loss therapy, "Wegovy."
Novo Nordisk A/S Sponsored ADR Class B (NVO.US) plans to apply for US regulatory approval for a high-dose version of its blockbuster weight loss therapy, "Wegovy." This is another important move for the company in the booming obesity treatment market to compete against rival Eli Lilly (LLY.US).
Martin HolstLange, Chief Scientific Officer of Novo Nordisk A/S Sponsored ADR Class B, stated that the high-dose Wegovy has similar weight loss potential to Lilly's Zepbound, providing patients with a new treatment option. He revealed at the European Association for the Study of Diabetes meeting in Vienna on Tuesday that while the company has not officially announced plans for the US market, they have already decided to submit an application for approval to the US Food and Drug Administration (FDA).
"Obviously, our competitors have optimized dosing," Lange said in an interview. "Now, we have also achieved the same goal with high-dose Wegovy."
Wegovy, like another drug by Novo Nordisk A/S Sponsored ADR Class B, Ozempic, is based on the core ingredient semaglutide. Currently, the company is building a diversified product portfolio around this ingredient, including high-dose injectables and an oral tablet version of Wegovy. As a pioneer in the obesity treatment market, Novo Nordisk A/S Sponsored ADR Class B is trying to regain its leading position in the industry through product development, having already lost some market share to Lilly in the crucial US market.
Earlier this year, Novo Nordisk A/S Sponsored ADR Class B submitted an application for high-dose Wegovy in Europe.
Additionally, Novo Nordisk A/S Sponsored ADR Class B also reiterated its plans to conduct late-stage clinical trials for the experimental compound cagrilintide. This compound, with a mechanism of action different from semaglutide, is derived from another intestinal hormone. It is worth noting that the company's next-generation obesity therapy, CagriSema, did not perform as expected in a large study; the company is now planning to adjust its research strategy, testing the efficacy of cagrilintide independently while optimizing the positioning of CagriSema through new clinical trials.
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