FDA Grants Approval to New Weight-Loss Medication

The Food and Drug Administration (FDA) has granted expedited approval to orforglipron, a new medication for weight loss. Branded as Foundayo, the drug is a GLP-1 receptor agonist, functioning similarly to popular injectable medications by mimicking a natural hormone that regulates appetite and feelings of fullness.

Availability and Pricing

Foundayo is expected to begin shipping on Monday. Eli Lilly, the manufacturer, announced that individuals with insurance may be able to access the medication for as little as $25 per month with a Lilly discount card. For those paying cash, prices will vary from $149 to $349 monthly, depending on the prescribed dosage.

Rapid Review Process

The FDA’s review of the application for orforglipron was completed in a swift 50 days. This expedited process highlights the agency’s focus on addressing obesity and related health concerns in the United States.

Clinical Trial Results

Significant Weight Loss Observed

Clinical trials involving over 3,000 adults with obesity demonstrated significant weight loss with orforglipron. Participants receiving the highest dose of 36 milligrams experienced an average body weight reduction of 11.2% – approximately 25 pounds – over a period exceeding 16 months, as reported in the New England Journal of Medicine.

Comparison to Existing Treatments

While injectable medications like Lilly’s Zepbound (21% average weight loss) and Novo Nordisk’s Wegovy (15% average weight loss) have proven effective, Foundayo offers a convenient oral alternative. Unlike Wegovy, which requires specific timing with water and an empty stomach, orforglipron can be taken without dietary restrictions.

Additional Health Benefits

Beyond weight loss, study participants using orforglipron also showed improvements in waist circumference, blood pressure, triglyceride levels, and cholesterol levels.

Side Effects and Considerations

Gastrointestinal Issues

The study indicated that between 5% and 10% of participants discontinued treatment due to side effects, primarily gastrointestinal issues. This compares to nearly 3% in the placebo group.

Accessibility Concerns

“Many more have trouble affording the costly shots,” stated a representative from a nonprofit health policy research group, highlighting the potential for Foundayo to broaden access to weight-loss treatments.