The Food and Drug Administration (FDA) has officially approved Foundayo, a new obesity pill developed by Eli Lilly, marking a significant advancement in the treatment options available for obesity. This approval marks the second GLP-1 medication in oral form, following the recent FDA green light for the pill version of Wegovy from Novo Nordisk.
Patients are now presented with an alternative to traditional injections, as both Foundayo and Wegovy offer oral options that could prove more appealing to many individuals struggling with obesity. Despite these advancements, the high costs associated with these medications and limitations in insurance coverage remain significant hurdles for patients seeking treatment.
The FDA’s rapid approval process for Foundayo highlights its status as a drug of national priority, with the review taking just 50 days—the quickest for a new drug since 2002. Unlike Eli Lilly’s injectable medicine Zepbound, Foundayo is based on a novel ingredient called orforglipron. This compound differs from traditional peptide-based treatments, making it easier for the body to absorb when taken in pill form. Eli Lilly’s Chief Scientific and Product Officer, Daniel Skovronsky, explained that the small molecule formulation allows for convenient dosing without food or water restrictions.
In contrast, Wegovy, which is peptide-based, has specific ingestion requirements: it must be taken on an empty stomach, requiring patients to fast for 30 minutes post-consumption. As a result, Foundayo may offer a simpler administration method, which could ultimately lead to improved adherence among users.
Clinical trials for Foundayo demonstrated promising results. Participants taking the highest dosage for 72 weeks lost an average of 27.3 pounds, equating to 12.4% of their body weight, compared to only 2.2 pounds (0.9% of body weight) in the placebo group. Common side effects reported included nausea, constipation, and diarrhea.
Notably, Novo Nordisk wasted no time in defending the efficacy of its own product, emphasizing that not all GLP-1 medications are equal. Jamey Millar, executive vice president for U.S. operations at Novo Nordisk, criticized claims comparing orforglipron’s effectiveness to Wegovy, noting the absence of head-to-head trials to substantiate such statements. Despite trial results showing Foundayo appeared slightly less effective, experts suggest real-world use could yield different outcomes, especially given the pill’s easier dosing regimen.
Dr. Catherine Varney, an obesity medicine director at UVA Health, argues that the convenience of pill dosing could lead to better outcomes for her patients, particularly those managing complex medication schedules. Conversely, she has observed that patients often are not deterred by injections but rather by cost, which remains a major barrier to accessing care.
In terms of pricing, Foundayo’s initial monthly cost is set at $149 for cash-paying customers. In comparison, Eli Lilly’s injectable Zepbound costs $299, making Foundayo a more affordable option for many. Although the company has yet to disclose the official list price that insurers will use for copay calculations, they expect copays could be as low as $25 for those with commercial coverage using an Eli Lilly savings card. Additionally, beginning in July, it is anticipated that Medicare recipients may be able to access the medication for $50 a month.
As for supply, Eli Lilly asserts that they have been manufacturing Foundayo in anticipation of demand, with expectations for the medication to be available in pharmacies within one to two weeks. As this new treatment option emerges, its impact on the obesity treatment landscape remains to be seen, particularly in light of the ongoing conversations around affordability and access in the healthcare system.
