With a little more than a month to go before Medicare beneficiaries can access pharmaceutical company Eli Lilly weight loss drug Foundayo at a $50 monthly copay through Medicare GLP-1 Bridge on July 1, the company announced Friday that the drug is associated with “significant body weight reductions in adults aged 65 and older.”
Medicare is a federal health insurance program for Americans age 65 and older as well as younger people with certain disabilities. Last December, the Centers for Medicare & Medicaid Services (CMS) announced that the Medicare GLP-1 Bridge would begin this summer. It’s a short-term program offering access to glucagon-like peptide-1 (GLP-1) weight loss medications.
This April, the U.S. Food & Drug Administration approved Foundayo, a GLP-1 tablet. Foundayo is the brand name of orforglipron, a small-molecule GLP-1 receptor agonist.
“The approval of orforglipron is another example of how the FDA’s [Commissioner's National Priority Voucher] pilot program has been able to more quickly bring effective treatments to Americans. Individuals who are overweight or obese now have an additional option to help with weight loss – a GLP-1 receptor partial agonist pill which does not need to be taken on an empty stomach,” said acting Center for Drug Evaluation and Research (CDER) Director Tracy Beth Høeg of the approval.
From 2021 to 2023, the prevalence of obesity in adults age 60 and older was 38.9%, according to the U.S. Centers for Disease Control and Prevention. With obesity comes increased risk for other health conditions, including high blood pressure, diabetes and some cancers, the CDC said.
Before the FDA approved Foundayo, pharmaceutical company Novo Nordisk released the first GLP-1 pill, a version of its Wegovy medication, in January. Wegovy, Ozempic and other popular GLP-1 drugs were initially available mostly in injection form.
GLP-1 drugs generally work by increasing the amount of insulin the body makes and decreasing gastric emptying which promotes a feeling of fullness. Most who take the medications experience a decrease in appetite and lose weight.
Foundayo is FDA-approved for adults with obesity and some adults who are overweight and have weight-related medical problems. It is prescribed alongside a reduced-calorie diet and physical activity. People on Foundayo only need a pill once daily. It can be taken any time of day with no food or water restrictions.
“Orforglipron was discovered by Chugai Pharmaceutical Co., Ltd. and licensed by Lilly in 2018,” Eli Lilly said. “In addition to chronic weight management, Foundayo is being studied as a potential treatment for type 2 diabetes, obstructive sleep apnea, osteoarthritis knee pain, hypertension, peripheral artery disease and stress urinary incontinence.”
Trials called ATTAIN have provided further information about Foundayo’s specific impact. According to Eli Lilly, these trials showed that the medication “was associated with clinically significant body weight reductions in adults aged 65 and older with obesity or overweight, with or without type 2 diabetes.”
In both ATTAIN -1 and ATTAIN-2 trials, participants received one of three once-daily doses of orforglipron, (5.5 milligram, 9 milligram, or 17.2 milligram) or a placebo. All doses were associated with “statistically significant reductions in body weight compared with placebo at 72 weeks,” in adults age 65 and older.
“Weight management in older adults requires careful consideration of both benefit and risk. These data are reassuring on both fronts – up to 13% weight loss was observed in patients 65 and older taking Foundayo, with a safety profile similar to what was observed in the broader trial populations,” said Rachel Batterham, M.D., senior vice president of medical innovation and external engagement at Lilly Cardiometabolic Health. “The fact that these results were achieved with a once-daily pill that patients can take at any time, without planning around meals or dealing with injections, matters in this age group.”
There are some risks associated with Foundayo. It should not be taken with other GLP-1 medications and it is not known if Foundayo is safe or effective for children. Also, it may cause tumors in the thyroid, including thyroid cancer. Those interested should consult with their doctor before taking Foundayo.
