Lilly’s Foundayo posts diabetes safety results

Eli Lilly said on April 16 that Foundayo, its once-daily GLP-1 pill, cleared a key heart-safety test in a late-stage diabetes trial. (investor.lilly.com) The study, called ACHIEVE-4, enrolled more than 2,700 adults across 15 countries with type 2 diabetes, overweight or obesity, and elevated cardiovascular risk. Lilly said it will use the results to file with the Food and Drug Administration for a type 2 diabetes indication by the end of the second quarter of 2026. (investor.lilly.com; cnbc.com) Heart-safety trials are the hurdle diabetes drugs must clear to show they do not raise the risk of major cardiac events in already high-risk patients. Lilly said Foundayo was non-inferior to insulin glargine on that measure, with a hazard ratio of 0.84, which translated to a 16% lower observed risk of cardiovascular death, heart attack, stroke or hospitalization for unstable angina. (investor.lilly.com) Foundayo is already on the U.S. market for weight loss after the Food and Drug Administration approved it on April 1 for adults with obesity, or overweight with at least one weight-related condition. The agency said that decision came 50 days after filing under its Commissioner's National Priority Voucher program. (fda.gov; accessdata.fda.gov) The diabetes data matter because Lilly is trying to turn the same pill into a treatment for two huge markets: obesity and type 2 diabetes. Oral GLP-1 drugs are a simpler alternative to injections, and Foundayo can be taken with or without food, unlike Novo Nordisk’s oral Wegovy, which CNBC reported must be taken on an empty stomach with a small amount of water. (accessdata.fda.gov; cnbc.com) Lilly also said ACHIEVE-4 showed stronger blood-sugar and weight results than insulin glargine at 52 weeks, and that those effects persisted through 104 weeks. In a preplanned analysis, the company reported a 57% lower risk of death from any cause, while noting the result was not controlled for multiplicity. (investor.lilly.com) The safety story is not over. An FDA approval letter posted this month requires Lilly to run post-marketing studies on cardiovascular events, delayed gastric emptying and other questions, while separate coverage of the letter said the agency also asked for more data on possible liver injury. (cnbc.com; biopharmadive.com) Foundayo’s label also carries a boxed warning about thyroid C-cell tumors, a class warning common to GLP-1 medicines, and says the drug is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2. The label says orforglipron did not produce tumors in rodents, but the relevance of GLP-1-related thyroid tumors to humans has not been determined. (accessdata.fda.gov) Lilly said ACHIEVE-4 found no liver safety signal, and RBC Capital Markets analyst Trung Huynh told CNBC the results should ease concern that Foundayo has a unique liver-risk problem versus rivals. The next test is whether the Food and Drug Administration accepts Lilly’s diabetes filing before the end of June and how much follow-up evidence regulators demand after that. (cnbc.com)