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FDA Approves New Weight Loss Pills
People looking to lose or maintain their weight now have new options
Novo Nordisk A/S: Wegovy® pill approved in the US as first oral GLP-1 for weight management
Courtesy Novo Nordisk
Key takeaways
- Two new once-daily GLP-1 weight loss pills won FDA approval, expanding options beyond injections.
- Both medications helped people lose weight and improve other weight-related conditions.
- The pills cost less than injectables and can cause similar side effects.
People prescribed GLP‑1 medications for weight loss now have options that do not require injections. Health regulators have approved two new GLP‑1 pills — one from the makers of Ozempic and Wegovy and another from the makers of Mounjaro and Zepbound.
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Two new medications hit the market
This past December, the once-daily Wegovy pill was the first oral GLP-1 to gain federal approval for weight loss.
In clinical trials, participants who took the highest dose of the pill lost an average of 16.6 percent of their body weight (approximately 32 pounds for a 200-pound person) after 64 weeks, the drug’s manufacturer, Novo Nordisk, said in a Dec. 22 news release. One in 3 people taking the oral medication lost at least 20 percent of their body weight.
The pill is also approved to help reduce the risk of serious cardiovascular events like nonfatal heart attacks and strokes.
And on April 1, the Food and Drug Administration (FDA) approved Foundayo (orforglipron), a pill for adults with obesity or who are overweight and have a weight-related medical condition.
In clinical trials, participants who took the highest dose of the once-daily pill achieved an average weight loss of 12.4 percent, or 27.3 pounds, after 72 weeks, compared with 2.2 pounds with the placebo. Researchers found that the medication also helped to mitigate other health issues, such as high cholesterol and high blood pressure.
It’s worth noting that a GLP‑1 pill (Rybelsus) containing a much lower dose of semaglutide — the same active ingredient as Wegovy — has been approved by the FDA since 2019 to treat type 2 diabetes. Its weight loss effect, however, is far less pronounced.
What are the side effects of GLP-1 pills?
Novo Nordisk, maker of the Wegovy pill, says the side effects of the oral option are similar to the injectable version. Many participants in the trial reported gastrointestinal issues, such as nausea and vomiting, when taking the medication.
For Foundayo, the most frequently reported side effects were mild to moderate and also gastrointestinal in nature, including nausea, constipation, diarrhea, vomiting, indigestion and stomach pain.
The Wegovy pill must be taken first thing in the morning on an empty stomach, with no food or drink for 30 minutes. Foundayo’s maker notes that it can be taken any time of day without food or water restrictions.
Expanding options for patients
Widening the pool of available options beyond injectables could help meet consumer demand more effectively. The active ingredients used to make Wegovy and Zepbound were in short supply for years. A recent poll among older adults found that 63 percent of people ages 50 to 80 who say they are overweight are interested in taking prescription weight loss medications.
While some people may prefer a weekly injection, Dr. Chetna Bakshi, a bariatric surgeon at Northwell Health’s Syosset Hospital in New York, told AARP that adding a pill to the mix could “offer more options for those patients who are unable to do the injections.”
It could also be a preferable choice for people who travel frequently, since the injectable medications require refrigeration. “A pill is very easy to take with you, so it definitely allows for more options for patients,” Bakshi says.
Another potential plus: price. While the injectable GLP-1 drugs can cost up to $1,000 a month, the price tag on the pills is much lower for people paying out of pocket.
For new patients, Novo Nordisk priced the Wegovy pill at $149 for the lowest dose and around $300 for the highest. Foundayo also starts at $149 per month for the lowest dose, according to Eli Lilly.
Many insurance plans, including Medicare, do not cover medications strictly for weight loss. However, Medicare is expected to cover the pills soon, at a copay of $50 a month, for some people who have certain health conditions.
While we wait for oral options to come to market, health experts say it’s important to talk to your health care provider about your weight loss goals and options if you’re struggling to lose weight.
GLP-1 treatments are not for everyone, Bakshi stresses, and like all medications, they can cause unpleasant side effects. What’s more, they are not recommended for patients with certain health conditions, including a history of medullary thyroid cancer.
“There’s no miracle drug. Everything comes with risks; everything comes with complications,” Bakshi says.
Editor’s note: An earlier version of this article was first published on July 3, 2023.
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