Pill Version of Wegovy Approved, Widening Access
- Published December 23, 2023, at 08:34 AM PST.Updated as new facts becomes available.
- On Monday, December 18, 2023, the Food and Drug Management (FDA) approved the oral version of Novo Nordisk's wegovy, a medication currently available as an injectable for weight...
- novo Nordisk plans to launch the oral Wegovy in January 2024.
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FDA Approves Oral Wegovy, Pioneering Pill for Weight Loss
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Published December 23, 2023, at 08:34 AM PST.Updated as new facts becomes available.
what Happened?
On Monday, December 18, 2023, the Food and Drug Management (FDA) approved the oral version of Novo Nordisk‘s wegovy, a medication currently available as an injectable for weight loss. This marks the first GLP-1 receptor agonist pill cleared by the FDA for treating obesity, potentially expanding access to a highly effective treatment for millions of Americans. The approval also includes an indication for reducing cardiovascular risks, mirroring the benefits of the injectable form according to the FDA proclamation.
How Effective is the Pill?
novo Nordisk plans to launch the oral Wegovy in January 2024. A late-stage clinical trial published in the new England Journal of medicine demonstrated that the 25-milligram dose – the highest dose expected to be sold – resulted in an average weight loss of approximately 14% among participants. This efficacy is comparable to the weight loss observed with the injectable Wegovy.
The trial involved a randomized, double-blind, placebo-controlled study design, considered the gold standard in medical research. Participants also experienced improvements in other health markers, such as blood sugar control and blood pressure.
| Wegovy Dosage | Average Weight Loss (%) |
|---|---|
| 25 mg (Oral) | ~14% |
| Injectable Wegovy | ~15% |
| Placebo | ~2% |
Pricing and Access: What to Expect
Novo Nordisk has not yet announced the pricing for the oral Wegovy. Currently, the injectable Wegovy costs around $1,349 per month without insurance. The company is exploring direct-to-consumer channels,offering cash prices without insurance,which are currently lower than the cash price for low-dose injectables.However, the final pricing for higher doses of the pill and what payers (insurance companies) will be charged remains unclear.
The availability of an oral formulation is expected to significantly increase access to this medication. Many patients prefer pills over injections, and the convenience of an oral medication could lead to higher adherence rates. However, affordability will be a crucial factor in determining how widely the oral Wegovy is adopted.
What are GLP-1 Receptor Agonists?
GLP-1 (glucagon-like peptide-1) receptor agonists are a class of drugs originally developed to treat type 2 diabetes. They work by mimicking the effects of the GLP-1 hormone, which helps regulate blood sugar levels, slows gastric emptying, and promotes feelings of fullness. These effects contribute to weight loss.
Other GLP-1 medications include: