- Federal regulators have approved the GLP-1 tablet Foundayo for use in weight management.
- Experts say having another weight loss medication in pill form could help people stick to a weight management regimen.
- They add that any weight loss medication regimen should be used in conjunction with a healthy diet and regular exercise.
- Even with approval, the FDA has instructed Eli Lilly to study the heart, liver, and other potential risks associated with this new pill.
Federal regulators have given the green light to a new GLP-1 weight loss tablet that people can take with or without food.
Officials at the Food and Drug Administration (FDA) have issued
Foundayo was approved for use in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain long-term weight reduction in adults with obesity or overweight with at least one weight-related comorbid condition.
Foundayo is now the second GLP-1 medication to be approved in pill form. A tablet form of the semaglutide-based drug Wegovy was given the go-ahead in January.
Foundayo is an oral GLP-1 receptor agonist taken once daily. The starting dosage is 0.8 milligrams (mg), increased to 2.5 mg after at least 30 days, and then to 5.5 mg after another 30 days. The dosage may be increased to 9 mg, 14.5 mg, or 17.2 mg after at least 30 days at each level based on treatment response and tolerability, according to the FDA.
Eli Lilly officials said Foundayo will be available via LillyDirect with prescriptions accepted immediately and shipping beginning April 6. Broad availability through U.S. retail pharmacies and telehealth providers is expected soon.
Company officials added that eligible people with commercial insurance may pay as little as $25 per month for the drug. Individuals opting for self-pay can purchase Foundayo for $149 per month for the lowest dose. Additionally, eligible Medicare Part D individuals may be able to get Foundayo for $50 per month, beginning as early as July 1.
Experts say the approval is a positive step toward managing obesity.
“It’s a significant milestone to have another GLP-1 tablet,” said Pouya Shafipour, MD, a family and obesity medicine physician at Providence Saint John’s Health Center in Santa Monica, CA.
Zhaoping Li, MD, the chief of the Division of Clinical Nutrition at UCLA Health and director of the UCLA Center for Human Nutrition in Los Angeles, also welcomed the news. “It is great to have new tools added to our toolbox to deal with obesity,” she told Healthline.
The Foundayo approval was conducted under the FDA’s
The approval followed two randomized, double-blind, placebo-controlled trials in adults who have obesity or overweight with one or more weight-related comorbidities. The trials lasted for 72 days.
Eli Lilly officials said that in the ATTAIN-1 trial, individuals taking the highest dose of Foundayo who stayed on treatment lost an average of 27 pounds, compared with 2 pounds for those given a placebo.
Like other GLP-1 drugs, Foundayo can cause side effects such as nausea, constipation, diarrhea, vomiting, abdominal pain, and headache, according to the FDA. The product also carries an FDA boxed warning regarding thyroid C-cell tumors.
According to a recently released approval letter, the FDA has instructed Eli Lilly to study potential risks associated with Foundayo, especially those related to the heart and liver.
The organization has encouraged the company to study serious conditions, such as stroke, heart attack, and liver injury that may be drug-related. This is because the FDA has noted that the current data isn’t enough to fully understand the potential risks.
The FDA is also requesting long-term information on potential links to thyroid cancer. It also asked for more information on delayed stomach emptying. This means food stays in the stomach longer than it should.
The FDA didn’t ask for these additional studies for the Wegovy pill when it was approved. However, Wegovy uses semaglutide, which has been studied for many years.
Foundayo, on the other hand, uses orforglipron. This is a newer active ingredient and lacks the same level of long-term safety data.
It is important to note that this doesn’t mean a safety concern has been found. It only means that the FDA wants more definitive long-term data.
Lilly officials noted that Foundayo can be taken with or without food.
The Wegovy pill needs to be taken on an empty stomach. People must wait 30 minutes before ingesting any food or drink.
“We believe Foundayo can help level the playing field for those living with obesity or who are overweight and living with weight-related complications,” said David Ricks, chair and chief executive officer of Eli Lilly, in a statement. “As a convenient, once-daily oral pill that delivers meaningful weight loss, this is obesity care designed for the real world.”
Shafipour said more research is needed before it’s known whether Foundayo can produce long-term results.
“We don’t know in reality how much weight people will lose,” he told Healthline. “We need to wait and see on that long-term data.”
Shafipour noted that tablet forms of GLP-1 medications could help people stick to weight loss routines.
“People are used to taking pills,” he said. “Getting a shot throughout your life is not fun.”
Mir Ali, MD, a bariatric surgeon and the medical director of MemorialCare Surgical Weight Loss Center at Orange Coast Medical Center in Fountain Valley, CA, said the type of GLP-1 medication prescribed varies from person to person.
“Preferences vary by patient,” he told Healthline. “Some prefer weekly injections while others prefer a [daily] pill. A primary advantage of the pill is that it does not require refrigeration, making it more convenient for travel.”
“While most studies indicate that oral forms may be slightly less effective than injections, they remain very effective. Ultimately, the choice depends on the patient’s lifestyle and personal preference,” Ali added.
There are a number of lifestyle habits you can adopt that can help you lose weight as well as manage your weight, whether or not you are taking GLP-1 medications.
Sharipour agreed with these suggestions and emphasized the importance of a diet high in protein and fiber as well as daily aerobic and strength-building exercise.
He added that quality sleep can help balance hormones and moderate hunger. He added that stress management can help with blood sugar levels.
Ali agreed that a proper diet is essential.
“The foundation of an effective diet — which we recommend to all patients regardless of whether they utilize surgery, medication, or counseling — is the reduction of carbohydrate and sugar intake. By emphasizing protein and non-starchy vegetables, the body is encouraged to utilize fat stores for energy, resulting in weight loss,” he explained.
Li said the best way to manage weight is to focus on lifestyle choices.
“Changing your lifestyle is challenging, but it is fundamental not only for weight loss but also for improving overall health (weight loss does not equal better health),” she noted. “Modern weight management no longer focuses solely on energy balance. It also places strong emphasis on the quality of the diet.”
