Foundayo: FDA Requests More Safety Data for Wegovy Alternative GLP-1 Pill
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The FDA has approved a new once-daily GLP-1 pill for weight loss. Image Credit: Healthline/Photo by Eli Lilly 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 fast-track approval to orforglipron, a “molecular entity” pill manufactured by Eli Lilly and sold under the brand name Foundayo. 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