The U.S. Food and Drug Administration (FDA) has approved the first oral medication for chronic weight management, providing a needle-free alternative to popular injectable GLP-1 drugs like Ozempic and Wegovy. This represents a significant shift in obesity treatment, offering increased accessibility and convenience for patients.
Wegovy Pill: Efficacy and Approval Details
Novo Nordisk’s Wegovy pill (semaglutide) is approved for adults with obesity or being overweight and having at least one weight-related health condition. The drug was also cleared to reduce the risk of severe cardiovascular events – heart attack, stroke, and death – in overweight or obese individuals with existing heart disease.
Clinical trials, including the OASIS 4 phase 3 study, have demonstrated that the Wegovy pill delivers comparable weight loss results to its injectable counterpart. Participants taking a daily 25mg dose lost an average of 13.6% of their initial body weight over 64 weeks, compared to just 2.2% in the placebo group.
- Roughly 80% of those on the pill lost at least 5% of their body weight.
- Half achieved a loss of 15% or more.
- Nearly 30% experienced a loss of 20% or greater, aligning with the results seen with injected GLP-1s.
Side Effects and Usage Considerations
While effective, the Wegovy pill does cause side effects in most patients. Approximately 74% of participants reported gastrointestinal issues like nausea and vomiting, leading to around 7% discontinuing treatment. These side effects are similar to those experienced with injectable GLP-1 medications.
The pill must be taken on an empty stomach with water at least 30 minutes before eating, drinking, or taking other medications to maximize absorption. The starting dose (1.5mg) will be available in January at $149 per month, with pricing for higher doses yet to be announced.
Accessibility and Future Options
The oral formulation may appeal to those who avoid injections, but cost and insurance coverage remain significant barriers. Many plans do not cover obesity medications, potentially limiting access.
Another GLP-1 oral treatment, orforglipron from Eli Lilly, is also under FDA review, with a decision expected early next year. This alternative has fewer restrictions on timing, potentially offering greater convenience.
The approval of Wegovy in pill form marks a step forward in obesity treatment, but broader access depends on addressing cost and insurance limitations.
This new option underscores the growing recognition of obesity as a chronic medical condition, and the need for more effective and accessible treatments.
