Oral version of obesity drug Wegovy sponsored by Novo Nordisk A/S ADR Class B(NVO.US) accepted by the US FDA application.
Noh and Nord stated that the US Food and Drug Administration (FDA) has officially accepted its marketing application for the oral version of the weight loss drug Wegovy and will make a decision in the fourth quarter.
Danish pharmaceutical giant Novo Nordisk A/S Sponsored ADR Class B (NVO.US) announced that the U.S. Food and Drug Administration (FDA) has officially accepted its marketing application for the oral version of the weight loss drug Wegovy, and a decision will be made in the fourth quarter.
If approved, this experimental once-daily oral formulation will become the world's first GLP-1 receptor agonist oral medication for chronic weight management.
With this positive news, Novo Nordisk A/S Sponsored ADR Class B saw its stock price on the U.S. market close up 5.53% at $69.23.
Currently, the company's oral GLP-1 medication Rybelsus (main ingredient semaglutide) is approved for blood sugar control in adults with diabetes.
In the weight loss drug market dominated by injectable formulations, pharmaceutical companies like Novo Nordisk A/S Sponsored ADR Class B and Eli Lilly are accelerating the development of more convenient oral weight loss medications. Industry forecasts indicate that the global obesity treatment market is expected to exceed $150 billion in the coming years.
Last month, Eli Lilly (LLY.US) reported that clinical data on its experimental oral drug orfoglipton showed that after 40 weeks of treatment, type 2 diabetes patients lost an average of 16 pounds (about 7.3 kilograms), equivalent to nearly 8% of their body weight.
The company plans to release additional trial data for the drug for weight management later this year, and intends to submit applications for weight loss indications to global regulatory agencies by the end of this year, with diabetes indications to follow next year.
Eli Lilly's injectable formulations Trulicity (used to treat diabetes) and Zepbound (used for weight loss) are sold under the Mounjaro brand.
Novo Nordisk A/S Sponsored ADR Class B's application is based on key Phase III clinical trial results. The study compared the efficacy of a 25 mg oral semaglutide dose with a placebo in 307 obese adults with at least one comorbidity.
In addition, the company is developing a new generation weight loss drug, amycretin, which targets not only the intestinal hormone GLP-1 that Wegovy mimics, but also the pancreatic hormone amylin that regulates hunger. The subcutaneous injection form is currently in the trial stage.
It is worth noting that investors have expressed concerns about Novo Nordisk A/S Sponsored ADR Class B facing fierce competition from Eli Lilly, and the clinical trial data for its new generation weight loss candidate CagriSema did not meet expectations, putting some pressure on the company, as this drug was originally hoped to be a potent alternative to Wegovy.
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