The US Food and Drug Administration (FDA) gave the green light on Wednesday to a new oral weight-loss medication developed by the Indianapolis-based pharmaceutical company Eli Lilly.
Known as orforglipron or brand name Foundayo, the once-daily tablet becomes the second GLP-1 drug in pill form to hit the market in a short span of time, arriving after Novo Nordisk’s Wegovy pill received approval in December.
The Food and Drug Administration (FDA) granted expedited approval to orforglipron, a GLP-1 drug that works similarly to widely used injectable treatments by mimicking a natural hormone that helps regulate appetite and feelings of fullness.
“Today, fewer than 1 in 10 people who could benefit from a GLP-1 are taking one, held back by access, stigma, perceived complexity or the belief that their condition isn’t serious enough for treatment,” said David A Ricks, chair and CEO of Eli Lilly, in a statement.
“We believe Foundayo can help level the playing field for those living with obesity or who are overweight and living with weight-related complications.”
Patients taking Foundayo are generally expected to begin with the smallest dose and gradually increase it to help limit side effects. Unlike the Wegovy pill, which must be taken first thing in the morning on an empty stomach, this medication can be taken at any point during the day without regard to meals.
The starting dose is projected to cost around $149 per month for those paying without insurance, similar to the Wegovy pill. Higher strengths may reach prices of up to $349 monthly. It remains uncertain how widely private insurance plans will cover it. However, under a proposal from the Trump administration, Medicare coverage could begin for certain patients as early as this summer, with copayments potentially as low as $50 per month.
This decision comes as the GLP-1 drug category continues to grow, with new treatments offering improved weight-loss results and, in some cases, reduced costs.
The daily pill will begin shipping Monday through its direct-to-consumer service, LillyDirect, and is expected to appear in pharmacies and telehealth services soon afterward, according to CNBC.
The availability of this pill could make weight-loss treatment more accessible to a large number of Americans who have avoided injectable options due to expense, discomfort with needles or rigid dosing rules. Because orforglipron is taken once per day in pill form, it may be easier for patients to stay consistent with treatment.
The approval follows Lilly’s submission of the drug to the FDA just a few months ago under a program designed to fast-track medications deemed to be of national importance. As a result, Foundayo will enter the market roughly three months after Novo Nordisk’s Wegovy pill, intensifying competition between the two companies in the evolving GLP-1 space.
