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- FDA approves Wegovy weight loss pill from Novo Nordisk (nbcnews.com)
FDA Greenlights Oral Wegovy: A New Chapter in Weight Loss Medication
The Food and Drug Administration (FDA) has officially approved an oral version of Novo Nordisk’s highly successful weight loss medication, Wegovy, marking a significant advancement in the treatment of obesity. This new pill is the first oral GLP-1 drug specifically brought to market for weight management, with another similar pill from Eli Lilly anticipated to receive approval in the coming months.
GLP-1 drugs, which include semaglutide (found in Novo Nordisk’s Ozempic and Wegovy) and tirzepatide (in Lilly’s Mounjaro and Zepbound), have seen a surge in popularity. Initially approved for diabetes, these compounds have demonstrated substantial weight loss benefits. Until now, all such medications were administered via injection, with the exception of Novo Nordisk’s Rybelsus, a lower-dose semaglutide pill for diabetes.
Dr. Christopher McGowan, a gastroenterologist specializing in weight loss, hailed the approval as “a meaningful step forward.”
He noted that while the pill won’t replace injectables, it significantly expands the available treatment options. “Pills are familiar, nonintimidating, and fit more naturally into most people’s routines,” Dr.
McGowan explained, adding that for many patients, a pill is not only easier but also “psychologically more acceptable.”
Cost and Coverage: Key Questions Remain
While Novo Nordisk has not yet announced the list price for the daily Wegovy pill, it is expected to be more affordable than the weekly injections. Insurance coverage, however, remains a critical concern.
Many private insurers currently limit coverage for the high-cost injectable versions. By law, Medicare is typically barred from covering weight loss medications.
However, the Wegovy pill’s additional approval for lowering heart disease risk could open doors for Medicare coverage, as it does cover treatments for cardiovascular conditions.
In a prior agreement with the Trump administration, Novo Nordisk committed to selling the lowest dose of the pill for $149 per month for out-of-pocket payers, in exchange for tariff relief. Eli Lilly has a similar agreement for its upcoming weight loss pill. Like its injectable counterpart, the pill will be available in various doses, with patients typically starting at the lowest dose and gradually increasing it to allow for adjustment to potential side effects.
Effectiveness and Practical Considerations
Clinical trial results, published in the New England Journal of Medicine, indicate that participants taking the highest dose of the Wegovy pill experienced an average weight loss of 16.6% over 64 weeks, compared to a 2.2% loss in the placebo group. This efficacy is comparable to the injectable Wegovy, which showed approximately 15% weight reduction over 68 weeks in its trials.
Dr. Shauna Levy, medical director of the Tulane Weight Loss Center, highlighted that adherence will likely be the biggest challenge for those opting for the pill.
It must be taken daily, first thing in the morning, on an empty stomach, with no more than 4 ounces of water. Patients in the clinical trial who did not strictly follow this regimen saw less weight loss, averaging 13.6%.
Dr. McGowan echoed this sentiment, questioning the “real-world performance” and whether patients will tolerate the daily dosing and strict timing required for meaningful results.
Common side effects, similar to the injections, are gastrointestinal, including nausea and vomiting. Dr.
McGowan noted that the pill’s side effects might feel “more intense” as the medication is absorbed all at once, potentially triggering more pronounced nausea. “The challenges we see with injectable GLP-1s don’t magically disappear with a tablet,” he cautioned.
While the Wegovy pill’s weight loss results align with its injectable form, Dr. Levy pointed out that oral GLP-1 drugs generally lead to less weight loss compared to some of the newer injectable options.
For instance, Lilly’s Zepbound resulted in an average weight loss of 22.5% over 72 weeks, and Lilly’s unapproved next-generation injection, retatrutide, showed 24% weight loss over 48 weeks. Dr.
Levy maintains that Zepbound currently stands as the most effective medical treatment for obesity, surpassed only by weight loss surgery.
Novo Nordisk attributes the differences in weight loss to the digestive process, where a portion of the oral medication is broken down before reaching the bloodstream. To counteract this, the pill contains a higher dose than the injections and requires daily administration.
The Wegovy pill’s effectiveness is more closely aligned with Lilly’s orforglipron, which showed approximately 10.5% weight loss over 72 weeks in a late-stage trial. However, direct head-to-head comparisons of these drugs have not been conducted.
Novo Nordisk anticipates widespread availability of the Wegovy pill in January. To prevent the prolonged shortages experienced with the initial launch of injectable Wegovy, the company has proactively ramped up production for the oral version.
Dr. McGowan also suggested that oral formulations are often easier to manufacture than injectables, which could further mitigate potential supply issues.
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