Following the recent approval of Foundayo (orforglipron), the U.S. Food and Drug Administration (FDA) is mandating a series of post-approval safety studies to further characterize the drug’s long-term profile.
Regulatory Mandates: The FDA determined that initial approval-era data were insufficient to fully characterize potential risks associated with this new molecular entity. The specific requests include:
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Long-term Monitoring: Gathering at least 15 years of data on thyroid cancer risks, consistent with the boxed warnings carried by existing injectable GLP-1 therapies.
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Cardiovascular and Hepatic Assessment: Additional evaluation of myocardial infarction, stroke, drug-induced liver injury, and delayed gastric emptying.
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Patient Registries: Establishing tracking systems for pediatric patients with obesity and monitoring outcomes in pregnant women using the medication.
Eli Lilly’s Response and Clinical Evidence: In response to the regulatory scrutiny, Eli Lilly released topline results from Achieve-4, the largest and longest study of Foundayo in type 2 diabetes to date. Key findings include:
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Cardiovascular Safety: Foundayo demonstrated non-inferior cardiovascular safety compared to insulin glargine, with a 16% lower observed risk of major adverse cardiovascular events.
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Therapeutic Efficacy: At 52 weeks, Foundayo users achieved an 8.8% reduction in body weight (compared to a 1.7% increase in the insulin group) and superior A1C reductions.
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Mortality Data: A pre-planned analysis indicated a 57% lower risk of all-cause death among patients treated with Foundayo.
Eli Lilly plans to submit Foundayo for a type 2 diabetes indication to the FDA by the end of the second quarter of 2026.
Source: https://www.pharmexec.com/view/eli-lilly-releases-updated-safety-data-foundayo-fda-request