Eli Lilly announced that its newly approved obesity pill, Foundayo, proved not inferior to long-acting insulin in reducing major cardiovascular risks among patients with type 2 diabetes and obesity. The development marks a significant step forward in the race to expand treatment options beyond injectable drugs.
Earlier this month, the U.S. Food and Drug Administration approved Foundayo for weight loss, intensifying competition with Novo Nordisk, whose oral Wegovy has been available since January. Consequently, the latest trial results strengthen Lilly’s position in the rapidly growing obesity and diabetes drug market.
Moreover, the company said it will seek U.S. approval for Foundayo to treat type 2 diabetes under the Commissioner’s National Priority Review Voucher program, which accelerates decisions on critical medicines. Lilly plans to submit its application by the end of the second quarter.
In a late-stage trial involving 2,700 high-risk patients, Foundayo reduced the risk of heart attack, stroke, or cardiovascular death by 16% compared with insulin glargine. Additionally, it lowered overall mortality risk by 57%. The drug also improved A1C levels and reduced body weight after 52 weeks of treatment.
Insulin glargine, marketed under brands such as Lantus and Basaglar, remains a widely used long-acting therapy for blood sugar control. However, oral alternatives like Foundayo are gaining attention for their convenience.
Meanwhile, regulators have requested further post-marketing data, particularly regarding potential liver risks. Nevertheless, Lilly reported no liver safety concerns in its analysis, consistent with earlier findings. Analysts believe these results may ease concerns about the drug’s safety compared to rivals.
