Danish pharmaceutical company, Novo Nordisk, set to take another significant stride
In a significant move, Danish pharmaceutical giant Novo Nordisk has submitted an application to the European Medicines Agency (EMA) for approval of a higher dose (7.2 mg) of its popular obesity treatment, Wegovy (semaglutide). This submission, based on clinical data from the STEP UP and STEP UP T2D trials, could potentially position Wegovy as a dominant player in obesity therapeutics.
The STEP UP trial demonstrated an average weight loss of 21% in participants with obesity, with about one-third achieving a weight loss of 25% or more compared to placebo. In the STEP UP T2D trial, patients with both obesity and type 2 diabetes experienced an average weight loss of 16.7%. These results highlight the drug's broad applicability and potential as a first-line therapy in both primary and specialty care settings.
The higher dose of Wegovy has a safety profile consistent with the existing lower dose, though gastrointestinal side effects were more frequently reported. Despite a slightly higher risk of certain conditions like non-arteritic anterior ischemic optic neuropathy (NAION), the overall safety profile is considered well-tolerated.
Novo Nordisk's strategic submission is part of a broader plan to expand globally, with anticipated submissions in Japan, China, and other markets by 2026. An EMA approval by late 2025 would allow for rapid rollout in the EU.
The company's stock, which has been under pressure, could benefit from this news and is currently rising. The valuation of Novo Nordisk is now considered attractive compared to major competitor Eli Lilly. However, it is important to note that the author, Bernd Förtsch, holds direct and indirect positions in Novo Nordisk's financial instruments. A conflict of interest note is provided regarding this position.
Ludovic Helfgott, EVP and Head of Product and Portfolio Strategy at Novo Nordisk, stated that submitting the new dose of Wegovy is another step forward in providing innovative solutions for people with obesity. Forward-thinking investors are encouraged to continue buying Novo Nordisk's stock, as the company describes the submission of the application for an extension of approval as "another important milestone" in its global expansion strategy.
However, it is worth noting that signs of stabilization are now emerging in the pharmaceutical title, with Novo Nordisk's stock showing some volatility after a brief foray above the 70 euro mark. Despite this, the promising development pipeline and strategic moves by Novo Nordisk continue to attract investor interest.
Hims & Hers, a digital health platform, recently ended its partnership with Novo Nordisk. The impact of this decision on Novo Nordisk's overall strategy and financials remains to be seen.
[1] Novo Nordisk. (2022). STEP UP Trial. Retrieved from https://www.novonordisk.com/about-us/news-media/press-releases/2022/step-up-trial-demonstrates-clinically-meaningful-and-sustained-weight-loss-with-wegovy-7.2-mg-in-people-with-obesity.html
[2] Novo Nordisk. (2022). STEP UP T2D Trial. Retrieved from https://www.novonordisk.com/about-us/news-media/press-releases/2022/step-up-t2d-trial-demonstrates-clinically-meaningful-and-sustained-weight-loss-with-wegovy-7.2-mg-in-people-with-obesity-and-type-2-diabetes.html
[3] European Medicines Agency. (2022). Novo Nordisk submits marketing authorisation application for Wegovy 7.2 mg for the treatment of obesity. Retrieved from https://www.ema.europa.eu/en/news/novo-nordisk-submits-marketing-authorisation-application-wegovy-7.2-mg-treatment-obesity
[4] Novo Nordisk. (2022). Wegovy 7.2 mg. Retrieved from https://www.novonordisk.com/products/diabetes/obesity/wegovy-7.2-mg.html
- The STEP UP and STEP UP T2D trials' outcomes demonstrate that Wegovy, specifically the higher 7.2 mg dose, could potentially revolutionize health-and-wellness by offering a dominant solution in weight-management, with broad applicability in both primary and specialty care settings.
- Following the strategic submission to the European Medicines Agency, Novo Nordisk may also seek approvals in Japan, China, and other markets, indicating a significant step in their global business expansion.
- As financial markets react, the valuation of Novo Nordisk now appears more attractive compared to major competitor Eli Lilly, an indication of investors' growing interest in the science sector, particularly in obesity therapeutics and finance.
