Eli Lilly said on Thursday its newly approved obesity pill was not inferior to a widely used long-acting insulin at lowering the risk of major heart problems in patients with type 2 diabetes and obesity.
The U.S. Food and Drug Administration approved the pill, Foundayo, for weight loss earlier this month, intensifying Lilly’s competition with Danish rival Novo Nordisk whose oral Wegovy has been on the market since January.
The late-stage study data also adds to the obesity drug’s potential in diabetes, boosting Lilly’s position in the multi-billion-dollar market, where drugmakers are racing to develop more convenient oral options as an alternative to injectables.
Lilly said it will seek U.S. approval of Foundayo for type 2 diabetes under the Commissioner’s National Priority Review Voucher, which aims to speed up FDA decisions on drugs deemed critical to public health or national security.
The company will submit an application by the end of the second quarter, it added.
The trial of 2,700 patients, who were at increased cardiovascular risk, showed Foundayo lowered the risk of heart attack, stroke or cardiovascular death by 16%, when compared with those on insulin glargine. The drug lowered the risk of death from any cause by 57%.
Foundayo also helped improve patients’ A1C levels – which measure average blood sugar levels over the past few months – and body weight at 52 weeks.
Insulin glargine, sold under brands such as Sanofi’s Lantus and Lilly’s Basaglar, is a long-acting, man-made insulin used to control blood sugar in type 1 and type 2 diabetes patients.
The FDA had asked Lilly for additional post-marketing studies and more data on liver injury for Foundayo.
Lilly said the trial also included an analysis of potential liver injury and found no liver safety concerns, consistent with earlier studies.
This data should allay fears that Foundayo faces unique liver safety risks versus competitors like oral Wegovy, said RBC Capital Markets analyst Trung Huynh.