What's Happening?
Novo Nordisk has announced significant results from its OASIS 4 phase 3 trial, which evaluated the efficacy of a new oral formulation of semaglutide, a drug traditionally administered via injection. The study, published in The New England Journal of Medicine,
involved 307 adults with obesity or overweight conditions, excluding those with diabetes. Participants who took the 25 mg oral semaglutide daily, alongside lifestyle changes, achieved an average weight loss of 16.6%, with over one-third losing 20% or more of their body weight. The trial also reported improvements in cardiovascular risk factors and physical activity levels. Novo Nordisk has submitted this oral formulation to the FDA for approval as the first oral GLP-1 therapy for long-term weight management.
Why It's Important?
The development of an effective oral weight loss medication could significantly impact the obesity treatment landscape in the U.S., where less than 2% of individuals with obesity currently receive medication. The oral semaglutide offers a more convenient alternative to injections, potentially increasing patient adherence and expanding treatment options. If approved, this drug could set a new benchmark for oral weight loss medications, addressing patient preferences and potentially increasing the number of individuals seeking treatment. The trial's results also reinforce the safety and efficacy profile of semaglutide, which has been used worldwide for weight management.
What's Next?
Novo Nordisk has already submitted a New Drug Application for the oral semaglutide to the FDA, with a review expected to conclude by the end of 2025. If approved, the drug will be manufactured in the U.S., with production already underway. The approval would mark a significant milestone in obesity treatment, providing a new option for patients who prefer oral medication over injections. The company anticipates high demand and is preparing to meet it with ample supply.
Beyond the Headlines
The introduction of an oral semaglutide could shift perceptions of obesity treatment, emphasizing the importance of addressing biological and environmental factors rather than viewing obesity solely as a result of personal choices. This development may also encourage further research and innovation in oral formulations of other injectable medications, broadening the scope of treatment options available to patients.
