Foundayo, a novel obesity medication developed by Eli Lilly, recently received approval from the Food and Drug Administration.
Eli Lilly
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Eli Lilly
The Food and Drug Administration has given its assent to another GLP-1 medication in pill form for obesity treatment, with Eli Lilly being the pharmaceutical company behind it.
Foundayo, this newly introduced daily pill, is set to rival Novo Nordisk’s oral Wegovy, which received FDA approval last December.
Individuals can now select between oral medications and injections from the two primary manufacturers of prominent obesity treatments. These pill alternatives may attract numerous patients. However, drug expenses and restrictions on insurance benefits continue to present challenges.
The FDA expedited the approval of Lilly’s obesity medication, classifying it as a national priority drug. According to the agency, the endorsement of Foundayo was finalized in just 50 days, making it the quickest approval for a novel drug type since 2002.
Despite being the developer of Zepbound, the highly successful injectable obesity treatment, Eli Lilly opted against converting Zepbound’s primary component into an oral form. Instead, the firm engineered a distinct active ingredient, scientifically termed orforglipron, which functions similarly to injectable peptide drugs without actually being one.
This implies that the human body can more readily absorb the active compound when taken as a pill, as noted by Daniel Skovronsky, Eli Lilly’s chief scientific and product officer.
“We have formulated a small molecule chemical that is highly bioavailable,” states Skovronsky. “It has the ability to replicate the actions of the peptide and offers greater convenience, as it can be consumed at any time of day without specific dietary or liquid intake requirements.”
The competing Wegovy pill is peptide-based. Peptides consist of short amino acid sequences. Wegovy’s oral version contains the identical active compound as its injectable counterpart, supplemented with an additional element to facilitate absorption prior to its breakdown by stomach acid. However, in contrast to Foundayo, the Wegovy pill necessitates consumption on an empty stomach, followed by a 30-minute fasting period for optimal effect.
Therefore, for certain individuals, Foundayo could offer enhanced convenience — and be less prone to incorrect administration.
Findings from one of the Lilly clinical studies examined by the FDA indicated that participants receiving the maximum prescribed Foundayo dose over 72 weeks experienced an average weight reduction of 27.3 pounds, or 12.4% of their initial body weight, while those on a placebo lost 2.2 pounds, or 0.9% of their average body weight. Frequently reported adverse reactions included nausea, constipation, and diarrhea.
Novo Nordisk launched a strong response to the competing oral medication. “Not all GLP-1s possess identical properties. Any assertions suggesting orforglipron surpasses the Wegovy pill in effectiveness for weight control are imprecise and deceptive,” declared Jamey Millar, executive vice president for U.S. operations at Novo Nordisk. “No direct comparative study has assessed the efficacy of orforglipron against the Wegovy pill … .”
During clinical investigations, the Lilly oral medication seemed marginally less potent than its rival, although direct comparative trials were not conducted. Its performance in actual patient settings might vary, notes Dr. Catherine Varney, who serves as the obesity medicine director for UVA Health in Charlottesville, Va.
She expresses that it would not astonish her if her patients using the latest pill achieve greater weight loss, given its ease of administration, particularly beneficial for individuals managing intricate medical schedules or those who find strict dosing challenging. “In such scenarios, one product will likely offer a slight edge. So… the outcome remains to be seen,” she comments.
Skovronsky of Lilly anticipates that Foundayo will attract patients who perceive injections as too significant a commitment.
“My ideal vision is for this medication to serve individuals who have not yet initiated a weight loss treatment,” he states. “They might be contemplating the severity of their condition, questioning if the disease warrants such intervention. Perhaps they are apprehensive about integrating an injection into their daily routine.”
However, Varney at UVA indicates that her clinical observations reveal that her patients are not typically deterred by injections. “I can confirm that among the more than 1,000 patients I oversee on GLP-1 therapy, needle aversion has never presented as a problem,” she affirms.
For her patients, the primary impediment to accessing treatment has been financial. She notes that all her patients using the Wegovy pill instead of injectable medications do so due to its greater affordability.
The initial dosage of Foundayo, similar to the Wegovy pill, is priced at $149 per month for individuals paying out-of-pocket without insurance. In contrast, Eli Lilly’s injectable obesity drug Zepbound has a cash price of $299 per month. While both medications become pricier at increased dosages, Foundayo offers a more economical option.
The corporation has yet to disclose an official list price, which typically serves as the baseline for insurance negotiations and the calculation of a patient’s copayment.
Lilly states that details regarding its insurance coverage will be clarified shortly. Nevertheless, for individuals holding commercial insurance, monthly copayments might be as minimal as $25 with an Eli Lilly savings card. Furthermore, from July onwards, Medicare beneficiaries could potentially acquire it for $50 monthly. Obtaining Medicaid coverage might necessitate a longer period.
Regarding availability, the company has been producing these tablets for some time and anticipates being able to satisfy consumer demand. Skovronsky projects their presence on pharmacy shelves within approximately “one to two weeks.”